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

NCT ID: NCT05639738

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2022-06-15

Brief 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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All subject

Clinical and instrumental measurements

Group Type: OTHER

Clinical and instrumental measurements

Intervention Type: OTHER

• Clinical evaluations
• Non-invasive instrumental measurements
• Subject's evaluations

Interventions

Clinical and instrumental measurements

• Clinical evaluations
• Non-invasive instrumental measurements
• Subject's evaluations

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject aged between 18 to 50 years included
• Subject 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 inclusion
• Subject with flare frequency ≥ 4 on the target areas over the last year
• Subject 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 subject
• Subject with a target area with 22 <= target SCORAD signs <= 10 following:

• Erythema ≥ 1
• Dryness ≥ 1 1
• Subject 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 investigator
• A sufficient distance from the cutaneous target area according to the investigator

Exclusion Criteria

• Subject with a surinfected AD
• Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments
• Subject 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 investigator
• Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator
• Systemic 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de Recherche sur la Peau

Toulouse, , France

Countries

France

Other Identifiers

ADFLAREPREDICT

Identifier Type: -

Identifier Source: org_study_id