Emollients in the management of atopic dermatitis in children: prevention of flares.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 409

Inclusion Criteria

Patients, male or female children, presenting with the following criteria may be included (V1):
Age between 2 and 6 years included,
- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
- Who has presented within the previous 6 months at least one duly documented flare treated by corticosteroids,
- Who present a current flare,
- Whose objective SCORAD score is [15-40] (grade 3) at inclusion,
- Whose parent(s) or guardian(s) has given his/her (their) written consent for their child's participation in the study,
- Whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints,
- Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
After treatment of the current flare, patients should have for randomization (V2):
- Objective SCORAD score is < 15,
- No lichenification, no excoriation, no oozing/crusts, no oedema/papulation,
- Erythema intensity < 1 (residual erythema area = 10% of extent),
- Xerosis intensity> 1,
- No pruritus, no sleep disorders (< 1 on VAS of SCORAD).
If lesions are not cleared in 21 days, patient cannot be randomized.
Are the trial subjects under 18? yes
Number of subjects for this age range: 409
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Criteria related to pathologies
- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- Primary bacterial, viral, fungal or parasitic skin infection,
- Ulcerated lesions, acne or rosacea,
- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- Immunosuppression,
- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
* Criteria related to treatments
- Use of oral corticosteroids or immunosuppressants during the last 14 days,
- Use of topical corticosteroids during the last 7 days,
- Use of systemic or local antibiotics on the lesions during the last 7 days,
- Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days,
- Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics),
- History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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