[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre for Human Drug Research, Netherlands\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100620577","deep-phenotyping-of-cindu-100620577",false,"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.",true,"ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","OBSERVATIONAL","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.",[25,26],"Skin Diseases","Angio-Oedema and\u002For Urticaria",[28,29],"Chronic inducible urticaria","Symptomatic dermographism","RECRUITING","2026-01-13",{"date":33,"type":34},"2026-01-22","ACTUAL",{"date":36,"type":34},"2025-01-21",{"date":38,"type":21},"2026-06-01",{"name":40,"class":41},"Centre for Human Drug Research, Netherlands","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100353544","phase-4-anti-inflammatory-effects-of-topical-erythromycin-and-clindamycin-in-acne-patients-100353544","NCT03883269","Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients","A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne","Inclusion Criteria:\n\n1. Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;\n2. Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and\u002For pustules), present at screening and baseline visit\n3. A maximum of 5 nodules present at screening and baseline visit\n4. Inflammatory acne present for at least 6 months\n5. Fitzpatrick skin type I-II (Caucasian)\n6. Able and willing to give written informed consent and to comply with the study restrictions.\n7. Willing to comply with 2x2mm facial skin punch biopsies\n\nExclusion Criteria:\n\n1. Severe acne where systemic treatment is needed\n2. Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline\n3. Use of any oral\u002Fsystemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline\n4. Use of systemic isotretinoin within 6 months prior to baseline\n5. History of pathological scar formation (keloid, hypertrophic scar)\n6. Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.\n7. Known contact dermatitis reaction to any product\n8. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.\n9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.\n10. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening\n11. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding","45 Years",{"count":52,"type":21},30,"INTERVENTIONAL",[55],"PHASE4","The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.",[58],"Acne Vulgaris","2019-03-18",{"date":61,"type":34},"2019-03-20",{"date":63,"type":34},"2018-03-20",{"date":65,"type":21},"2019-12",{"name":40,"class":41},1,""]