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Terminated NCT05639738

Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD

Conditions: Dermatitis, Atopic

Sex: All
Ages: 18 Years – 50 Years
Phase: NA
Enrollment: 12
Sponsor: Pierre Fabre Dermo Cosmetique

Location: France

Summary

The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.

Eligibility Criteria

Inclusion Criteria:Subject aged between 18 to 50 years includedSubject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6)Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusionSubject with flare frequency ≥ 4 on the target areas over the last yearSubject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subjectSubject with a target area with 22 <= target SCORAD signs <= 10 following:Erythema ≥ 1Dryness ≥ 1 1Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as :A non- usual AD flare area according to the subject and the investigatorA sufficient distance from the cutaneous target area according to the investigatorExclusion Criteria:Subject with a surinfected ADSubject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessmentsSubject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigatorAny surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigatorSystemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period)Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period)Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05639738). StuddyBuddy aggregates publicly available trial information.