Study to evaluate the efficacy and tolerance of a new restorative cream in association with a corticosteroid in adults with Atopic Dermatitis

• Conditions: Atopic Dermatitis (arms, popliteal fossa); MedDRA version: 17.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-002194-10-DE
• Lead Sponsor: Pierre Fabre Dermo-Cosmétique

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-11
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Criteria related to the population:
•Patient male or female
•Patient aged between 18 and 65 years included
•Patient with phototype I, II, III or IV according to Fitzpatrick classification
•Patient having signed his/her written informed consent for his/her participation in the study
•Patient affiliated to a social security system or health insurance, or is a beneficiary
•For women of childbearing potential :
ohaving been using an effective method of contraception (chirurgical or hormonal birth control or intrauterine device only) for at least 2 months before inclusion in the study,
oaccepting to go on using it during the whole duration of the study and up to 5 days after the last product application, in order to avoid pregnancy while being exposed to the study products
onegative urine pregnancy test

Criteria related to the disease:
•Patient with a diagnosis of Atopic Dermatitis for at least one year
•Patient with moderate to severe Atopic Dermatitis lesions symmetrical in terms of severity on both arms or on both popliteal fossa, whose scores index severity are as follows:
oL-IGA = 3 or 4 (moderate or severe) assessed on a scale ranged from 0 to 5
oL-SCORAD = 6 assessed on a 18-point scale with:
?xerosis score = 2 (moderate) on a scale ranged from 0 to 3
ono difference by more than 1 score point between each component of the L-SCORAD of both arms or of both popliteal fossa
ono more than 3 points of difference in the total L-SCORAD
•Patient with Atopic Dermatitis lesions symmetrical in terms of extent on both arms or on both popliteal fossa: target lesions with a similar size on both arms or on both popliteal fossa, according to the judgement of the investigator

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Criteria related to the population:
•Patient unable to understand the information given (for linguistic or psychiatric reasons) and to give his/her consent in writing to participate
•Patient unable to understand the study procedures (for linguistic or psychiatric reasons) and to report required information in writing in his/her diary
•Patient who has forfeited his/her freedom by administrative or legal award or under guardianship
•Patient who is currently participating or who has participated in another clinical study within 1 month prior to inclusion visit
•Patient who, in the judgement of the investigator, is not likely to be compliant during the study
•For women: patient pregnant or breastfeeding

Criteria related to the disease
•Skin disease on the study arms or legs other than AD liable to interfere with the assessment
•Primary bacterial, viral, fungal or parasitic infections on the application areas
•Ulcerated lesions on the application areas
•History of disease considered by the investigator hazardous for the patient or incompatible with the study
•On-going allergen reintroduction
•On-going reintroduction diet within the framework of avoidance regimen (food allergy(ies))
•Reintroduction diet
•History of hypersensitivity or intolerance to any component of the test product and/or associated product’ ingredients

Criteria related to treatments and products
•Phototherapy for less than 4 weeks prior to inclusion or required during the study
•Systemic immunosuppressive treatment within 4 weeks before the inclusion or required during the study
•Systemic corticosteroids within 2 weeks before the inclusion or required during the study
•Systemic antihistaminic established or modified within 2 weeks before the inclusion
•Systemic antibiotics within 1 week before the inclusion or required during the study
•Topical immunomodulators (TIMs), non-steroidal anti-inflammatory, corticosteroids, antihistaminics, antibiotics or antiseptics treatments applied on study arm(s) or leg(s) within 5 days before the inclusion or required during the study
•Skin care product (including moisturizer) applied on study arm(s) or popliteal fossa within 2 days before the inclusion visit
•Water or any cleansing product, applied on study arm(s) or popliteal fossa 4 hours before the inclusion visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified