[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-diseases":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,52,84,117,147,170,203,233,258,293,325,358,383,421,447,474],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100181078","phase-2-effects-of-treatments-on-atopic-dermatitis-100181078",false,"NCT01631617","Effects of Treatments on Atopic Dermatitis","Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis","* INCLUSION CRITERIA:\n\nCohorts 1 \\[NO FURTHER ACCRUAL\\], 2 \\[INACTIVE\\], 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers\n\n* Males and females aged 18-50 years at time of initial protocol sampling\n* Subjects must participate fully and be willing to comply with the procedures of the protocol\n* Subjects must be co-enrolled in NIH protocol 08-HG-0059\n* Ability of subject to understand and provide written informed consent\n* Access to bathing facilities (Cohort 2 \\[INACTIVE\\])\n* Ability to swallow capsules or tablets\n\nCohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients\n\n* Subjects must be aged 2-50 years\n* Subjects must be co-enrolled in NIH protocol 08-HG-0059\n* Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis\n* Subjects must have a primary care provider\n* Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe\n* Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and\u002For pustules)\n* Access to bathing facilities\n* All subjects and\u002For their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with\n\nthe procedures of the protocol and provide informed consent. Pediatric patients will be included in age appropriate discussions and\n\nage appropriate assent will be obtained in accordance with NIH guidelines.\n\n-Ability of subject to understand and provide written informed consent\n\nCohort 6: Healthy Volunteers\n\n* Subjects previously enrolled in Cohorts 1 \\[NO FURTHER ACCRUAL\\] and 4 \\[INACTIVE\\] who completed on-protocol antibiotic regimen\n* Subjects must participate fully and be willing to comply with the procedures of the protocol\n* Ability of subject to understand and provide written informed consent\n\nEXCLUSION CRITERIA:\n\nCohorts 1 \\[NO FURTHER ACCRUAL\\] and 2 \\[INACTIVE\\]: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Any female with symptoms and\u002For serum hormone levels consistent with perimenopause or menopause\n* Use of systemic antibiotics in 12 months preceding baseline sampling\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling\n* Use of topical or oral complementary\u002Falternative medicine (CAM) agents within 4 weeks of initiation of treatment\n* Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine\n* Family history of toxic epidermal necrolysis\n* Known allergy or sensitivity to sodium hypochlorite (NaOCl)\n* History of AD or asthma\n* Inability to comply with the requirements of the protocol\n* Pregnant or lactating\n* Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy\n* Any chronic past or present medical illness, including chronic skin diseases like psoriasis\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants\n* Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals\n\nCohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients\n\n* Does not meet inclusion criteria\n* Any female with symptoms and\u002For serum hormone levels consistent with perimenopause or menopause\n* Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine\n* Family history of toxic epidermal necrolysis\n* Known allergic reaction to sodium hypochlorite (NaOCl)\n* Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling\n* Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling\n* Use of topical or oral CAM agents within 4 weeks of initiation of treatment\n* Subjects with known primary or acquired immunodeficiency\n* Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to baseline sampling\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives (whichever is the longer time period) of initiating treatment on this protocol\n* Subjects who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months\n* Pregnancy or lactating\n\nCohorts 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Any female with symptoms and\u002For serum hormone levels consistent with perimenopause or menopause\n* Use of systemic antibiotics in 12 months preceding baseline sampling\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling\n* Use of topical or oral complementary\u002Falternative medicine (CAM) agents within 4 weeks of initiation of treatment\n* (Cohort 4 \\[NO FURTHER ACCRUAL\\]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine\n* (Cohort 5 \\[INACTIVE\\]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine\n* Family history of toxic epidermal necrolysis\n* History of AD or asthma\n* Inability to comply with the requirements of the protocol\n* Pregnant or lactating\n* Subjects with a primary or acquired immunodeficiency, including HIV seropositivity\n* Any chronic past or present medical illness, including chronic skin diseases like psoriasis\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants\n* Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals\n\nCohort 6: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling\n* Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling\n* Pregnant or lactating females in all cohorts are excluded from participating due to the potential effects of the above listed antimicrobials on the developing human fetus or nursing infant; listed in Sections 11.1 through 11.5. Females of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Lactating mothers will discontinue breastfeeding prior to study enrollment.\n* Smokers and subjects who use smokeless tobacco products are excluded in all cohorts due to tobacco s unknown impact on human oral mucosa and microflora.",true,"ALL","2 Years","50 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\n\\- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin.\n\nObjectives:\n\n\\- To study the effect of eczema treatments on skin bacteria.\n\nEligibility:\n\n* Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.\n* Healthy volunteers between 18 and 40 years of age with no history of eczema.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed.\n* All participants will be assigned to one of several study groups.\n* Healthy volunteers must not have taken antibiotics in the year before the start of the study.\n* All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits.\n* Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.",[28,29,30,31,32],"Eczema","Dermatitis","Skin Diseases, Genetic","Dermatitis, Atopic","Skin Diseases",[34,35,36,37,38],"Investigator-Blinded","Skin Biopsy","Randomized","Antibiotics","Topical","RECRUITING","2026-06-27",{"date":42,"type":43},"2026-06-30","ACTUAL",{"date":45,"type":43},"2012-09-18",{"date":47,"type":22},"2027-01-01",{"name":49,"class":50},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100494824","phase-3-a-study-of-baricitinib-ly3009104-in-children-from-6-years-to-less-than-18-years-of-age-with-alopecia-areata-100494824","NCT05723198","A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata","BRAVE-AA-PEDS","Inclusion Criteria:\n\n* Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).\n* Have severe areata alopecia (AA) for at least 1 year\n* Diagnosis for at least 1 year\n* Current AA episode of at least 6 months' duration\n* SALT score ≥50% at screening and baseline\n* History of trial and failure with at least 1 available treatment (topical or other) for AA\n* History of psychological counseling related to AA\n* Current episode of severe AA of less than 8 years.\n\n  * Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.\n\nExclusion Criteria:\n\n* Primarily \"diffuse\" type of AA (characterized by diffuse hair shedding).\n* Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.\n* Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden\n* Have uncontrolled arterial hypertension\n* Have had major surgery within 8 weeks prior to screening or will require major surgery during the study\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and\u002For unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.\n* Have a positive test for hepatitis B virus (HBV) infection\n* Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \\[RNA\\]).\n* Have evidence of human immunodeficiency virus (HIV) infection and\u002For positive HIV antibodies.","6 Years","17 Years",{"count":63,"type":22},595,[65],"PHASE3","The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.\n\nThe study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension (LTE) Period, and a 4-week Post-treatment Follow-up period. Some individuals may be eligible to receive treatment after completing the LTE, for a maximum of 180 weeks.",[68,69,70,71,32,72],"Areata Alopecia","Alopecia","Hypotrichosis","Hair Diseases","Pathological Conditions, Anatomical","2026-05-18",{"date":75,"type":43},"2026-05-20",{"date":77,"type":43},"2023-02-27",{"date":79,"type":22},"2033-09",{"name":81,"class":82},"Eli Lilly and Company","INDUSTRY",127,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":16,"sex":17,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":51},"100637454","biomedical-signal-extraction-from-symptom-descriptions-an-observational-registry-using-the-opengenome-platform-100637454","NCT07578610","Biomedical Signal Extraction From Symptom Descriptions: An Observational Registry Using the OpenGenome Platform","Accuracy and Calibration of Evidence-Grounded Biomedical Signal Extraction From Free-Text Symptom Descriptions: A Prospective Observational Registry Using the OpenGenome Automated Research Instrument","OGNOME-REG","* Automated or programmatically generated submissions detected by rate limiting\n* Submissions containing no discernible symptom or health-related content","18 Years",{"count":94,"type":22},1000,"OBSERVATIONAL","This registry prospectively collects anonymized free-text symptom descriptions submitted voluntarily by adults through the OpenGenome platform at opengenome.bio. For each submission, the system retrieves real biomedical literature from PubMed and ClinicalTrials.gov in parallel, applies a constrained reasoning model operating under a strict output schema, and returns a structured biological signal report. The study evaluates the internal consistency of extracted signals, the calibration of confidence scores relative to dataset size and symptom specificity, and the distribution of biological signal categories across a large anonymous population. No intervention is assigned. No participant contact occurs. All data is anonymized at the point of collection.",[98,99,100,32,101,102],"Signs and Symptoms","Fever","Myalgia","Hemorrhagic Fever With Renal Syndrome","Zoonoses",[104,105,106],"biomedical signal extraction","symptom analysis","PubMed","2026-05-16",{"date":109,"type":43},"2026-05-19",{"date":111,"type":43},"2026-05-05",{"date":113,"type":22},"2028-05-30",{"name":115,"class":116},"OpenGenome","NETWORK",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":51},"100489129","early-phase-1-repurposing-dupilumab-for-management-of-pruritic-genetic-inflammatory-skin-disorders-100489129","NCT05649098","Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders","Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders: a Single-Site Pilot Study","Inclusion Criteria:\n\n1. Male or female \\> 6 months of age at screening visit\n2. Clinical diagnosis of a genetic skin disorder at the screening visit, ideally with genetic or histological confirmation.\n3. Must have had the gene with one or more variants identified by genotyping. If the genotype has not been performed or has not been performed at a CLIA-approved laboratory, be willing to provide a sample (saliva, buccal swab, blood) for genetic testing before starting the dupilumab.\n4. Average Itch Numerical Rating Scale (NRS) ≥ 4 and Worst Itch NRS of at least 5 during the previous 7 days (self-reported if \\>8 years old; proxy reported if under 8 years)\n5. Must be willing to provide information weekly about Average and Worst Itch\u002Fself- or proxy-assessed severity and wear the sensor device to track itch and sleep weekly throughout the first 24 weeks of the trial (Parts A and B).\n6. Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n7. Subject, parent\u002Fcaregiver or legal guardians, as appropriate, are able to understand and complete the study requirements and study-related questionnaires\n\nExclusion Criteria:\n\n1. Subjects \\\u003C 6 months of age at screening visit.\n2. Unable to provide informed consent or assent (or who do not have consent from a Legally Authorized Representative if \\\u003C 18 years).\n3. Diagnosis of ichthyosis vulgaris as the sole inherited disorder\n4. Used of dupilumab within 5 drug half-lives (105 days) of baseline visit\n5. Subjects who have used any of the following treatments within 4 weeks, or within a period equal to 5 times the half-life of the drug, before the baseline visit, whichever is longer:\n\n   1. Immunosuppressive\u002Fimmunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.), systemic anti-inflammatory medication, or phototherapy\n   2. Other biologics: within 5 half-lives (if known) or 16 weeks, whichever is longer\n6. Initiation of topical or systemic retinoids, topical keratolytics, or topical anti-inflammatory agents within 4 weeks before study start\u002FPart A (systemic retinoids and topical medications\u002Femollients can be used during the trial if started at least 4 wks before the observation period and continued throughout Parts A and B). Note: Rescue therapy for disease flares or local infection will be allowed per investigator discretion but must be for no more than a total of 1 week during any 4-week period and, if topical, involve application to less than 10% BSA.\n7. Subjects with active infections or recent history of serious infections, malignancies or history of malignancies, or any severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or psychiatric cerebral disease, or signs or symptoms thereof. It is recognized that patients with ichthyosis may have arthritis, while patients with junctional or dystrophic EB may have a variety of associated issues (eg nutritional, anemia, etc). The decision to include will be based on investigator's discretion but must reflect the likelihood for stable disease and lack of anticipated interference with assessment of itch.\n8. Treatment with a live (attenuated) vaccine within 4 weeks before the Week 0 visit when dupilumab is initiated; use of vaccination during the study requires consultation with the study investigator and primary care provider.\n9. Active acute or chronic infection requiring treatment with systemic antibiotics\u002F anti-virals\u002F anti-fungals within 2 weeks before the initiation of dupilumab (start of dupilumab can be delayed). Delay in initiation because of treatment with a topical antimicrobial to a localized superficial site will be determined by the investigator.","6 Months",{"count":126,"type":22},30,[128],"EARLY_PHASE1","Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.",[32],[132,133,134,135,136],"Itch","Pruritus","epidermolysis bullosa","ichthyosis","genetic skin disorders","2026-04-27",{"date":139,"type":43},"2026-05-01",{"date":141,"type":43},"2023-06-12",{"date":143,"type":22},"2032-06-01",{"name":145,"class":146},"Northwestern University","OTHER",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":16,"sex":17,"minAge":92,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":51},"100624673","phase-1-a-study-to-evaluate-the-safety-of-bg-a3004-in-healthy-participants-and-patients-with-immune-mediated-skin-diseases-100624673","NCT07412691","A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases","A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases","Inclusion Criteria\n\n* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 180 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug.\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 180 days after the last dose of study drug.\n\nPart A (SAD) specific Inclusion criteria\n\n* Healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.\n* Body mass index (BMI) of 19 to 28 kg\u002Fm\\^2\n\nPart B (MAD) specific inclusion criteria:\n\n* Must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n* Body mass index (BMI) of 18 to 32 kg\u002Fm\\^2\n* Patients with alopecia areata (AA), clinical diagnosis of AA with no other etiology of hair loss. Severity of Alopecia Tool (SALT) ≥ 25 and \\\u003C 95 at screening and randomization.\n* Patients with cutaneous lichen planus (CLP), clinical and histological features of LP with predominant cutaneous involvement. Investigator's Global Assessment (IGA) score of 3 or 4 at screening and randomization.\n* Patients with nonsegmental vitiligo (NSV), documented clinical diagnosis of NSV for at least 3 months. Facial-Vitiligo Area Scoring Index (F-VASI) ≥ 0.5 and Total body-VASI ≥ 3 at screening and randomization.\n\nExclusion Criteria:\n\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of the study drug or drugs of the same class.\n* Participants who are unable to comply with the requirements of the protocol, unless the written approval of the medical monitor has been obtained before informed consent.\n* Participants with any malignancy ≤ 5 years before randomization, except for any locally recurring cancer that has been treated curatively\n* Participants who were administered a live vaccine ≤ 28 days before randomization.\n* Female participants who are pregnant or are breastfeeding.\n* History of Tuberculosis or active, latent, or inadequately treated infection\n* A known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predispose the participant to infections.\n* Known infection with hepatitis B virus \\[presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody( HBcAb)\\], or presence of hepatitis C virus antibody (HCV Ab)\n* Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus-related lymphoproliferative disorder, as reported in some participants on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.\n* Have an active infection or a history of infection within 6 months before the first dose of study drug that required hospitalization, or parenteral antimicrobial therapy, or have a history of opportunistic infection or a chronic or recurrent infectious disease that, in the opinion of the investigator, makes them unsuitable for this study.\n* Have or have had symptomatic herpes zoster or herpes simplex within 12 weeks, more than 1 episode of local herpes zoster, or a history (single episode) of disseminated zoster.\n* Acute disease state (e.g., asthma attack, nausea, vomiting, fever, or diarrhea) within 7 days prior to the first dose of study drug.\n\nPart B(MAD) specific exclusion criteria:\n\n* Previous use of any Janus Kinase (JAK) inhibitor for any disease indication at any time.\n* Treatment with systemic immunomodulatory medications within 4 weeks or 5 half-lives (if known), whichever is longer prior to randomization, including immunosuppressants (e.g., methotrexate, cyclosporine, azathioprine); corticosteroids administered orally, intravenously, or intramuscularly; chloroquine derivatives; and oral phosphodiesterase-4 (PDE4) inhibitors (e.g., apremilast).\n* Phototherapy (UV or laser therapy) or cryotherapy within 4 weeks prior to randomization.\n* For AA patients, AA that affects more than scalp hair, e.g., eyebrow, eyelash, body hair.\n* For CLP patients, Patients whose LP is a predominantly bullous variant.\n* For NSV patients, Participants who have no pigmented hair within any of the vitiligo areas on the face.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","60 Years",{"count":156,"type":22},98,[158],"PHASE1","This is the first-in-human study of BG-A3004. The study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of BG-A3004 after single and multiple doses administered in different dose levels in healthy participants (Part A) and patients with immune-mediated skin diseases (Part B), respectively.\n\nStudy details include:\n\n* The study duration will be approximately 3 years.\n* The treatment duration will be 1 dose for Part A and 4 doses for Part B.\n* Safety follow-up period is 168 days after the last dose",[32],"2026-03-20",{"date":163,"type":43},"2026-03-23",{"date":165,"type":43},"2026-03-19",{"date":167,"type":22},"2028-08-08",{"name":169,"class":82},"BeOne Medicines",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":51},"100545879","clinico-biological-collection-of-autoimmune-dysimmune-or-auto-inflammatory-dermatological-diseases-100545879","NCT06387654","Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases","Constitution of a Collection of Biological Samples With the Aim of Carrying Out Clinico-biological and Physiopathological Investigations of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases","TekAPo","Inclusion Criteria:\n\nSkin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin.\n\nThe patients included may be adults or children, and will be:\n\n* Patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others),\n* Patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example),\n* Patients with cutaneous lupus\n* Patients with dysimmune skin diseases (psoriasis, eczema)\n* Patients with immuno-induced dermatological disorders or drug dermatitis\n* Patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, checkpoint inhibitors, gene therapy, cell therapy, etc.).\n\nPatients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected\n\nExclusion Criteria:\n\n* Patients under protective supervision (guardianship, curators)\n* Patients under 6 years old\n* Pregnant or breastfeeding woman","99 Years",{"count":180,"type":22},800,"The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.",[183,184,185,32],"Autoimmune Bullous Dermatosis","Dysimmune Dermatological Diseases","Auto-inflammatory Dermatological Diseases",[187,188,189,190,191,192,193],"auto-inflammatory dermatological diseases","Cutaneous lupus","scleroderma","dermatomyositis","psoriasis","eczema","new therapies","2026-03-16",{"date":196,"type":43},"2026-03-17",{"date":198,"type":43},"2024-05-06",{"date":200,"type":22},"2034-04",{"name":202,"class":146},"University Hospital, Toulouse",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":178,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100559376","phase-2-guselkumab-in-the-treatment-of-adults-with-pyoderma-gangrenosum-pg-100559376","NCT06563323","Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)","A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum","GEORGE","Inclusion Criteria:\n\n* Willingness to comply with study procedures\u002Frequirements\n* Capable of giving informed consent\n* Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.\n* Undergoing at least once a week standard of care wound care at home or at a wound care facility\n* Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg\u002Fday for at least two weeks prior to first drug administration.\n* Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be sure that female partner(s) are using birth control that works well or not have sex.\n* Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study for at least 12 weeks following the last dose of guselkumab.\n* Willingness to travel to study site for all study visits or living \\>30 miles from study site and willing\u002Fable to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.\n* Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies at week 16. Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.\n\nExclusion Criteria:\n\n* Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab\n* Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:\n\n  1. 12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;\n  2. 8 weeks for infliximab;\n  3. 6 weeks for adalimumab;\n  4. 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK\u002FTYK pathway and PD4 inhibitors;\n  5. 2 weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).\n\nIf not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.\n\n* Intralesional corticosteroids within 4 weeks of screening.\n* Active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.\n* Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for irritable bowel disease (IBD) or rheumatoid arthritis), are allowed as combination therapy except for Methotrexate (MTX) and Leflunomide which are allowed individually but not in combination.\n* Concurrent skin disease that is deemed to interfere with assessment of ulcer.\n* Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mm Hg.\n* Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.\n* Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate in the study (40 weeks) which in the opinion of the investigator would pose an unacceptable risk to the subject.\n* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.\n* Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: Neutrophil count \\\u003C1500 cells\u002FµL, Lymphocyte count \\\u003C500 cells\u002FµL, Platelet count \\\u003C100,000 cells\u002FµL, AST or ALT or alkaline phosphatase \\> 2 times the upper limit of normal, Hemoglobin \\\u003C10 g\u002FdL, Serum creatinine ≥1.5 mg\u002FdL (SI: ≤137 μmol\u002FL), White blood cells \\\u003C3500 cells\u002F µL\n* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.\n* Individuals who are pregnant, lactating or breastfeeding.\n* History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.\n* Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.\n* Have signs or symptoms suggestive of active Tuberculosis (TB) upon medical history and\u002For physical examination. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. For participants with a history of treated latent TB there must be documentation of appropriate treatment prior to the first administration of study intervention.\n* Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates immunity to the disease and will not be exclusionary.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).\n* Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug administration for Bacillus Calmette-Guérin (BCG) vaccine.\n* Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate families (spouse, parent, child, or sibling).\n* Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.",{"count":212,"type":22},17,[25],"A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)",[216,32,217,218,219],"Pyoderma Gangrenosum","Wound Heal","Pyoderma","Skin Ulcer",[221,222],"Guselkumab","IL-23 Inhibitor","2026-03-04",{"date":225,"type":43},"2026-03-06",{"date":227,"type":43},"2025-02-01",{"date":229,"type":22},"2027-08-13",{"name":231,"class":146},"Oregon Health and Science University",2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":16,"sex":17,"minAge":92,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100620577","deep-phenotyping-of-cindu-100620577","NCT07359430","Deep Phenotyping of CIndU","An Exploratory, Multi-centre, Two-part Study to Describe Chronic Induced Urticaria Characteristics and Explore Novelbiomarkers With a Multimodal Patient Profiling Approach by Comparing CIndU Patients to Chronic Spontaneousurticaria Patients and Healthy Volunteers","Inclusion Criteria:\n\nHealthy volunteers\n\n* Male and female subjects between 18-69 years of age; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination and vital signs.\n* No clinically significant skin disease in the research area\n* No history of hypertrophic scarring or keloid.\n* Willing to give written informed consent and willing and able to comply with the study protocol.\n* Negative TempTest and FricTest at screening.\n* Participant is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 12 hours before study visit 1.\n\nEligible patients:\n\n* Male and female subjects aged ≥18 years\n* Diagnosis of SD, ColdU or CSU (moderate to severe according to international guidelines (Zuberbier et al, 2022)) for ≥3 months and symptomatic disease despite treatment with H1 antihistamines (up to fourfold the approved dose).\n* Patients currently on an antihistamine (up to fourfold the approved dose) must be on a stable dose for at least 2 weeks prior to day 1 and must maintain the same stable dose throughout the treatment period. Patients are according to the stepped care model eligible to start treatment with omalizumab\n* Willing to give written informed consent and willing and able to comply with the study protocol.\n* Positive provocation test:\n\n  1. For ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening and Baseline. Alternatively, patients with a negative TempTest® may also be included if they have a positive ice cube test;\n  2. For SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3mm at both screening and Baseline.\n* For CSU patients: negative TempTest® and FricTest® at screening\n* Participant is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 12 hours prior to Day 1 and EOS.\n* Female participants of reproductive potential must agree to use contraception from screening until EOS.\n\nExclusion Criteria:\n\n* Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder\u002Ftherapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease.\n* History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.\n* Loss or donation of blood over 500 mL within three months prior to screening.\n* Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIB ab) at screening\n* Known infection requiring (topical or oral) antibiotic therapy within 56 days prior to Day 1.\n* The use of systemic antibiotic therapy for \\>2 months the past 12 months.\n* The use of any oral\u002Fsystemic medication (e.g. immunomodulatory, immunosuppressive) within 28 days prior to Day 1, if the investigator judges that it may interfere with the study objectives.\n* Treatment with omalizumab within 5 half lives (120 days) prior to Day 1\n* Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding.\n* Have any current and\u002For recurrent clinically significant or subject reported skin condition other than the CInDU\u002FCSU wherefore subject is included in the study.\n* Evidence of current drug or alcohol abuse.\n* History of regular alcohol consumption within 12 months of the trial defined as an average weekly intake of \\>21 alcoholic drinks\u002Fweek for men or \\>14 alcoholic drinks\u002Fweek for women (i.e., 1 drink is equivalent to 150 mL of wine or 360 mL of beer or 45 mL of hard liquor)\n\nHealthy volunteers\n\n\\- Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year.\n\nEligible patients\n\n* For CIndU patients: active CSU or other forms of CIndU besides ColdU or SD that may interfere with study assessments. For CSU patients: presence of active CIndU disease that may interfere with study assessments.\n* Urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).\n* Active, pruritic skin condition in addition to CIndU (CIndU patients) or CSU (CSU patients).\n* Routine doses of the following medications within 30 days prior to Day 1: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.\n* Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.\n* Regular (daily\u002Fevery other day) doxepin (oral) use within 6 weeks prior to Day 1.\n* Any H2 antihistamine use within 7 days prior to Day 1.\n* Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 1.\n* Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.\n* Hypersensitivity to omalizumab or any component of the formulation.\n* History of anaphylactic shock.\n* Evidence of parasitic infection.",{"count":241,"type":22},40,"Chronic inducible urticaria (CIndU) is a group of skin disorders defined by recurrent itchy or burning wheals or angioedema that recur for more than six weeks with a specific triggering factor. This is different from chronic spontaneous urticaria which does not have a specific triggering factor. CIndU is subclassified in nine subtypes with each having its own specific trigger. These subtypes are further divided in physical urticarias (symptomatic dermographism, cold urticaria, delayed pressure urticaria, solar urticaria, heat urticaria, vibratory angioedema) or non-physical urticarias, i.e., cholinergic urticaria, aquagenic urticaria, and contact urticaria.\n\nSymptomatic dermographism (SD) is the most prevalent subtype of the physical urticarias. Its prevalence in Western populations is estimated to be between 1-5%. Following SD, cold urticaria (ColdU) is the next most common form, its annual incidence is estimated to be 0.05%. In this study, patients with the ColdU and symptomatic SD subtypes will be enrolled.\n\nAs of yet, disease diagnosis of SD and ColdU is mostly purely clinical (clinical picture + patients' history), as there is a lack of objective biomarkers. Currently only two objective tools are available for the diagnosis of SD and ColdU, which are the FricTest and Temptest (both provocation tests). In addition, there is a lack of objective biomarkers for the prediction of treatment response and for the monitoring of treatment effects, as this is nowadays only monitored by patient reported outcomes.",[32,244],"Angio-Oedema and\u002For Urticaria",[246,247],"Chronic inducible urticaria","Symptomatic dermographism","2026-01-13",{"date":250,"type":43},"2026-01-22",{"date":252,"type":43},"2025-01-21",{"date":254,"type":22},"2026-06-01",{"name":256,"class":146},"Centre for Human Drug Research, Netherlands",3,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":266,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":281,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":268},"100586616","phase-3-a-study-to-learn-about-the-safety-and-efficacy-of-the-drug-oleogel-s10-in-japanese-patients-with-epidermolysis-bullosa-100586616","NCT06917690","A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa","Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)","REVIVE","Inclusion Criteria:\n\n1. Male or female aged ≥ 21 days\n2. Confirmed diagnosis of either JEB or DEB\n3. Both biological parents and all 4 grandparents of Japanese descent\n4. At least 3 EB wounds that meet the following criteria at the time of enrollment:\n\n   * All are located outside of the anogenital region\n   * All are distinguishable from any other wounds on the subject's body (separated by a minimum of 5 cm)\n   * At least one has been present for a minimum of 21 days but less than 9 months AND is 10 cm2 to 50 cm2 in size\n   * At least two have been present for a minimum of 21 days but less than 9 months AND\u002FOR are 10 cm2 to 50 cm2 in size\n5. A female subject must meet one of the following criteria:\n\n   * If of childbearing potential, she must:\n\n     1. Have a negative pregnancy test result at Screening and Baseline Visits, AND\n     2. Agree to use one of the following highly reliable methods of contraception from the day of the informed consent signature until the day after the last Oleogel- S10 application. The following methods are acceptable:\n\n        * Placement of an intrauterine device (IUD) or intrauterine releasing system (IUS)\n        * Combined (both estrogen and progestogen) hormonal contraception (oral) associated with inhibition of ovulation, supplemented with a barrier method (preferably male condom)\n        * Bilateral tubal occlusion\n        * Sexual abstinence, defined as refraining from heterosexual intercourse during the entire study period\n        * Partner vasectomy, provided that the partner is the sole sexual partner and has received medical verification of the surgical success\n   * Be of non-childbearing potential, defined as one of the following:\n\n     * Pre-menarche, OR\n     * Post-menopausal (12 consecutive months of amenorrhea without an alternative medical cause), OR\n     * Permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy (supporting evidence required)\n6. Subject and\u002For subject's legal representative has been informed about the study, has read and understood the information provided, and has given written informed consent\n7. Subject and\u002For subject's legal representative is able and willing to follow all study procedures and instructions\n\nExclusion Criteria:\n\n1. Hypersensitivity to Oleogel-S10 or any of its excipients\n2. Diagnosis of EB subtypes simplex or Kindler EB\n3. Receipt of systemic antibiotics for wound-related infections within 7 days prior to enrollment\n4. Receipt of systemic or topical (on EB wounds) steroids within 30 days prior to enrollment Exceptions: Inhaled, ophthalmic, or mucosal applications, such as budesonide suspension for esophageal strictures\n5. Receipt of immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrollment Note: Dupilumab to manage pruritis is allowed if the subject has been on a stable dose for more than 3 months prior to baseline\n6. Receipt of systemic gene therapy for the treatment of inherited EB\n7. Receipt of short-acting stem cell therapy (infusion of Muse cells, allogeneic adipocyte-derived MSC sheet (topically applied), TEMCELL (allogeneic MSCs, subcutaneous injection)) within 6 months prior to study enrollment\n8. Receipt of topical gene therapy for the treatment of inherited EB (e.g., beremagene geperpavec) within 3 months prior to enrollment\n9. Receipt of a JACE® skin graft on any of the target wounds\n10. Current and\u002For former malignancy, including skin malignancies such as basal cell carcinoma and squamous cell carcinoma\n11. Females: Pregnant or lactating, or of childbearing potential with a fertile male partner and unwilling to use a highly reliable method of contraception from the informed consent signature until study participation ends\n12. Enrollment in any other interventional study or treated with any other investigational drug for any disease within 4 weeks prior to enrollment\n13. Presence of any factor in the subject and\u002For legal representative that could interfere with study compliance, such as the ability to attend the scheduled study visits or to properly manage the dressing changes at home","21 Days",{"count":268,"type":22},6,[65],"The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population. Children and adults may participate. The trial also looks at the safety of Oleogel-S10 gel. The main questions it will answer are:\n\n* Does Oleogel-S10 gel close wounds from JEB or DEB within 45 days or reduce the size of the wounds?\n* Are there any medical problems when using Oleogel-S10 gel?\n* How much of the drug ends up in your blood?\n\nThe study has 2 parts. In Part 1, participants will:\n\n* Apply Oleogel-S10 gel to the EB wound dressings at least once every 4 days for 45 days.\n* Visit the clinic once every 2 weeks for checkups and tests. If participants complete Part 1, they may participate in Part 2 if they choose to. In Part 2, participants will continue to receive Oleogel-S10 gel until the product is available to buy in Japan or until the trial is stopped by the company.",[272,273,274,275,276,277,278,32,279,280],"Epidermolysis Bullosa","Junctional Epidermolysis Bullosa","Epidermolysis Bullosa, Dystrophic","Epidermolysis Bullosa, Junctional","Skin Abnormalities","Connective Tissue Disease","Collagen Diseases","Genetic Diseases, Inborn","Congenital Abnormalities",[282,283],"Filsuvez","Birch Bark extract","2025-12-18",{"date":286,"type":43},"2025-12-22",{"date":288,"type":43},"2025-04-18",{"date":290,"type":22},"2029-09",{"name":292,"class":82},"Chiesi Farmaceutici S.p.A.",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":16,"sex":17,"minAge":92,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":51},"100497633","oct-vibrography-for-biomechanical-properties-of-tissues-100497633","NCT05759780","OCT Vibrography for Biomechanical Properties of Tissues","A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues","Group 1:\n\nInclusion criteria:\n\n• Subjects with healthy eyes (age 18 - 75, N = 50)\n\nExclusion criteria:\n\n* Subjects with history of eye diseases, and previous eye surgeries.\n* Subjects with diabetes, glaucoma family history\n* Subjects allergic to anesthetic eyedrop, especially proparacaine\n* Subjects with severe allergy\n* Subjects who have difficulty biting\n* Subjects who have recurrent corneal erosion\n\nGroup 2:\n\nInclusion criteria:\n\n• Subjects with healthy skin (age 18 - 75, N = 10)\n\nExclusion criteria:\n\n• Subjects with open cuts\u002Fsores on the skin, skin infection, or any contagious skin condition\n\nGroup 3:\n\nInclusion criteria:\n\n• Subjects with healthy gingiva (age 18 - 75, N = 10)\n\nExclusion criteria:\n\n• Subjects with open cuts\u002Fsores on the gingiva, gingiva infection, or any contagious gingiva condition\n\nGroup 4:\n\nInclusion criteria:\n\n• Mild or moderate keratoconus subjects (age 18 - 40, N = 20)\n\nExclusion criteria:\n\n• Subjects with K-max above 60 diopters (Pentacam imaging) are excluded","75 Years",{"count":302,"type":22},90,[304],"NA","The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo.",[307,32,308],"Cornea","Gingival Diseases",[310,311,312,313,314,315],"biomechanics","cornea","skin","gingiva","optical coherence tomography","vibrography","2025-10-21",{"date":318,"type":43},"2025-10-23",{"date":320,"type":43},"2023-08-19",{"date":322,"type":22},"2026-08-28",{"name":324,"class":146},"Massachusetts General Hospital",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":333,"maxAge":4,"enrollmentInfo":334,"targetDuration":336,"studyType":95,"phases":4,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100543224","abrocitinib-taiwan-treatment-pattern-and-real-world-study-in-atopic-dermatitis-attract-registry-100543224","NCT06353087","Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry)","The Real-world Treatment Patterns and Clinical Outcomes in Moderate-to-severe Atopic Dermatitis (AD) Patients Receiving Abrocitinib","ATTRACT","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Patients aged ≥12 years\n2. Patients with confirmed diagnosis of moderate-to-severe AD as assessed by the physician\n3. Patients for whom the physician's decision has been made to newly prescribe abrocitinib in usual clinical practice conditions\n4. Evidence of a personally signed and dated informed consent\u002Fassent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Any prior use of abrocitinib\n2. Simultaneous participation in a study that includes administration of any investigational drug or procedure","12 Years",{"count":335,"type":22},200,"12 Months","This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics.",[31,29,28,32,339,340],"Immune System Diseases","Janus Kinase Inhibitors",[342,343,344,345,346,347],"Atopic Dermatitis","Abrocitinib","JAK inhibitors","Real world","Registry","Taiwan","2025-09-02",{"date":350,"type":43},"2025-09-03",{"date":352,"type":43},"2024-07-01",{"date":354,"type":22},"2026-05-15",{"name":356,"class":82},"Pfizer",8,{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":257},"100605158","skin-reactions-related-to-thoracic-implantable-chamber-dressings-100605158","NCT07158879","Skin Reactions Related to Thoracic Implantable Chamber Dressings","KPAREAC","Inclusion Criteria:\n\n* Patients over 18 years of age\n* New chemotherapy patients (1st line of treatment only)\n* Thoracic PAC\n\nExclusion Criteria:\n\n* PICC Line and femoral PAC;\n* Patients undergoing treatment with bi-specific antibodies (e.g. tebentafusp);\n* Disunion requiring treatment\n* Patients treated for hematological cancer;\n* Persons deprived of their liberty or under guardianship (including curatorship);\n* Adults under court protection;\n* Inability to participate in the study for geographical, social or psychological reasons.\n* No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.).\n* Opposition to data use","100 Years",{"count":367,"type":22},500,"Prospective, multicenter cohort of 500 patients newly treated with systemic chemotherapy with CCI. The main objective of this study is to measure the incidence of skin reactions related to thoracic implantable chamber dressings.",[32],[371,372,373],"cancers treated with chemotherapy","skin reaction","dressings","2025-08-28",{"date":376,"type":43},"2025-09-08",{"date":378,"type":43},"2025-06-10",{"date":380,"type":22},"2026-12-10",{"name":382,"class":146},"Institut Curie",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":16,"sex":17,"minAge":92,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":51},"100599985","an-observational-study-to-assess-objective-skin-pigmentation-variation-100599985","NCT07091604","An Observational Study to Assess Objective Skin Pigmentation Variation.","Objective Skin Pigmentation Assessment in Healthy Volunteers and in Patients With Skin Disease: An Observational Study Using Non-invasive Skin Imaging","SKIN-IMAGING","Inclusion Criteria:-\n\n* Age ≥ 18 years\n* Ability to understand oral and written Dutch or English\n\nExclusion Criteria:\n\nFor study cohort #1 (Healthy volunteers):\n\n* Extensive tattoos covering \\>50% of the total body area\n* Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks\n* Use of self-tanner products in the last 3 weeks\n\nFor study cohort #2 (Patients):\n\n* Extensive tattoos covering \\>50% of the total body area\n* Extensive skin lesions covering \\>50% of the total body area\n* Recent extensive sun exposure (e.g. sun tanning booth or stay in a tropical country) in the last 3 weeks\n* Use of self-tanner products in the last 3 weeks",{"count":392,"type":22},600,"Accurate assessment of skin pigmentation is essential in dermatology for properly diagnosing and managing a wide range of skin conditions. Traditionally, skin colour has been evaluated through visual inspection or by using classifications like the Fitzpatrick skin type. However, these methods can be subjective, culturally biased, and often are centered around lighter skin tones, which may lead to misdiagnosis or inappropriate treatment for individuals with darker skin.\n\nWith advances in technology, non-invasive imaging tools such as colorimetry and multispectral imaging now offer more precise and objective ways to measure skin pigmentation. These methods can help provide consistent and unbiased information about skin tone, benefiting both clinical care and research. Despite these technological advances, there is currently no agreed-upon standard for how to measure skin pigmentation objectively in everyday clinical practice or research settings.\n\nThis study aims to explore better, more accurate ways to measure skin pigmentation using modern, non-invasive imaging technologies. Traditional methods for assessing skin colour, like visual inspection or classifying by ethnicity, are often unreliable and biased. In this study, researchers will use tools such as colorimetry and multispectral imaging to measure skin pigmentation more objectively.\n\nThe study includes two groups of participants: healthy adults and adults with skin conditions. Researchers will measure a value called the melanin index, which reflects the amount of pigment in the skin, and compare it across different areas of the body and among people with different skin tones and conditions.\n\nThe goal is to understand how skin pigmentation varies and to see if these new technologies can help doctors more accurately diagnose and manage skin diseases for people of all skin types.",[32,395],"Healthy Skin",[397,398,399,400,401,402,403,404,405,406,407,408,409,410,411],"Skin pigmentation","Melanin index","Colorimetry","Multispectral imaging","Line-Field Confocal Optical Coherence Tomography","Skin parameters","Skin colour","Skin color","Etnicity","TEWL","Erythema index","Non-invasieve measurement","Skin Disease","Skin of Colour","Laser speckle contrast imaging","2025-07-29",{"date":414,"type":43},"2025-08-01",{"date":416,"type":22},"2025-07-22",{"date":418,"type":22},"2027-01-22",{"name":420,"class":146},"Leiden University Medical Center",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":16,"sex":17,"minAge":92,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":257},"100592114","multi-modal-quantitative-imaging-of-the-skin-100592114","NCT06989216","Multi-modal Quantitative Imaging of the Skin","DermaFlow Alpha - Multi-modal Quantitative Imaging of the Skin","DermaFlow","Inclusion criteria:\n\n* Adult patients that are part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.\n* Patients with signed informed consent\n\nExclusion criteria:\n\n* Cognitive impairment\n* Patients unable to understand the oral and written study information in Swedish or English\n* Other severe disorder or terminal disease\n* Patients unable to provide an informed consent\n* Patients not able to keep balance, while standing up with closed eyes, without any aid\n* Claustrophobic patients",{"count":430,"type":22},8000,"This clinical trial is about evaluating the suitability of multi-modal imaging technology, which covers virtually the entire body, to evaluate the possibility of screening and early detection of disease.",[433,32,342,434,435,436,437],"Skin Cancer","Psoriasis","Raynaud Disease","Diabetic Foot","Peripheral Arterial Disease","2025-05-16",{"date":440,"type":43},"2025-05-25",{"date":442,"type":43},"2023-02-01",{"date":444,"type":22},"2026-02-01",{"name":446,"class":82},"HJN Sverige AB\u002FNeko Health",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":454,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":51},"100581438","phase-2-herbal-ointment-in-treating-atopic-dermatitis-topically-100581438","NCT06850311","Herbal Ointment in Treating Atopic Dermatitis Topically","Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Between 18 and 65 years old, female or male.\n2. Atopic dermatitis fulfilling the diagnostic criteria of Hanifin\\&Rajka.\n3. Atopic dermatitis involving \\\u003C10% of BSA. (Base on the BSA result of Screening)\n4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)\n5. Female patients of child-bearing age with negative pregnancy test at screening.\n6. Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.\n\nAgree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0) Willing to comply with study protocol and agree to sign an informed consent form.\n\nExclusion Criteria:\n\n1. Having a history of topical or systematical hypersensitivity to herbal or its excipient (e.g. vehicle) in ointment\n2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.\n3. Having used topical or oral therapy (e.g. topical corticosteroids, antibiotic, TCM) for dermatitis within 7 days before the first application of the study medication.\n4. Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.\n5. Having abnormal liver or renal function (AST\u002FALT \\>3 x ULN, creatinine \\>2.0 mg\u002Fdl).\n6. Women who are lactating, pregnant or preparing to be pregnant.","65 Years",{"count":456,"type":22},66,[25,65],"Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disorder. The current first-line recommended treatment for AD is the use of emollients, topical corticosteroids (TCS), and oral antihistamines if necessary. However, patients often have side effects like skin atrophy and telangiectasia. And there were plenty of herbal medicine which are beneficial to atopic dermatitis in ancient Chinese medicine books and records. Therefore, the purpose of this study is to develop a new topical application of traditional Chinese medicine and evaluate its clinical efficacy in AD patients. In human trial, 66 Subjects diagnosed as AD will be enrolled and treated with Sophora flavescens Aiton topical ointment. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.\n\nThe 1st year project: (1) Expect to enroll 66 clinical subjects of AD. (2) Evaluate subjects 'symptom and proceed herbal ointment treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.\n\nThe 2nd year project: (1) Completing enrollment of 66 clinical subjects of AD. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.",[342,460,461,462,463,32,464,30],"Atopic Dermatitis (AD)","Atopic Dermatitis (Eczema)","Atopic Dermatitis Eczema","TCM","Skin Diseases, Eczematous","2025-02-23",{"date":467,"type":43},"2025-02-27",{"date":469,"type":22},"2025-03-01",{"date":471,"type":22},"2027-04-01",{"name":473,"class":146},"En Chu Kong Hospital",{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":503,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":513,"leadSponsor":514,"locationsCount":51},"100567960","clinical-trial-assessing-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-in-nonhealing-dfus-and-vlus-100567960","NCT06674980","Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","C5CAMP","Inclusion Criteria for DFU:\n\n1. At least 18 years of age or older.\n2. Must have diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.\n4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.\n5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n6. Target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n7. Subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and \\\u003C= 1.3\n   2. TBI \\>= 0.6\n   3. TCOM \\>= 40 mmHg\n   4. PVR: biphasic\n8. If subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.\n10. Subject must consent to using the prescribed offloading method for the duration of the study.\n11. Subject must agree to attend weekly study visits.\n12. Subject must be willing and able to participate in the consent process.\n\nExclusion Criteria for DFU:\n\n1. Subject is known to have a life expectancy of \\\u003C 6 months.\n2. Subject's target ulcer is not secondary to diabetes.\n3. Target ulcer is infected or there is cellulitis in the surrounding skin.\n4. Target ulcer exposes tendon or bone.\n5. Evidence of osteomyelitis complicating the target ulcer.\n6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. Subject is taking hydroxyurea.\n9. Subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.\n14. Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.\n16. Subject has end stage renal disease requiring dialysis.\n17. Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n19. Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.\n20. Subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria for VLU:\n\nPotential subjects are required to meet all the following criteria for enrollment in the study.\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n6. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n7. The potential subject must agree to attend the weekly study visits required by the protocol.\n8. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria for VLU:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n3. The target ulcer exposes tendon or bone.\n4. There is evidence of osteomyelitis complicating the target ulcer.\n5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n8. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n9. The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n10. Women who are pregnant or considering becoming pregnant within the next 6 months.\n11. The potential subject has end stage renal disease requiring dialysis.\n12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n14. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n15. The subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n16. A subject has a wound with active or latent infection is excluded.\n17. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":483,"type":22},177,[304],"The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.",[487,488,489,490,491,492,493,494,495,219,32,496,497,498,436,499,500,501,502],"Pathologic Processes","Diabetes Mellitus","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Disease","Diabetic Angiopathies","Vascular Diseases","Cardiovascular Diseases","Leg Ulcer","Diabetes Complications","Diabetic Neuropathies","Foot Diseases","Foot Ulcer","Diabetes Mellitus, Type 2","Ulcer","Foot Ulcer Unhealed",[504,505,506,507,508],"Human Placental Membrane (HPM)","Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Cellular, Acellular, and Matrix-like Product (CAMP)","Cellular and\u002For Tissue-Based Product (CTP)","2024-12-20",{"date":511,"type":43},"2024-12-27",{"date":509,"type":43},{"date":418,"type":22},{"name":515,"class":82},"C5 Biomedical"]