[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-diseases-genetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-diseases-genetic":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"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":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"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.","18 Years","65 Years",{"count":62,"type":22},66,[25,64],"PHASE3","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.",[67,68,69,70,71,32,72,30],"Atopic Dermatitis","Atopic Dermatitis (AD)","Atopic Dermatitis (Eczema)","Atopic Dermatitis Eczema","TCM","Skin Diseases, Eczematous","2025-02-23",{"date":75,"type":43},"2025-02-27",{"date":77,"type":22},"2025-03-01",{"date":79,"type":22},"2027-04-01",{"name":81,"class":82},"En Chu Kong Hospital","OTHER"]