Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 232

Inclusion Criteria

- Age between 2 and 6 years included,
- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
- With xerosis on the body and a xerosis score > 2 (SCORAD sub-score) on the anterior part of lower limbs,
- Whose objective SCORAD score is < 15 at inclusion,
- Associated signs such as hyperlinearity in the palms and/or scales on the lower limbs,
- 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).

Are the trial subjects under 18? yes
Number of subjects for this age range: 232
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
- Acute phase of atopic dermatitis with moderate/severe erythema, mild/moderate/sever excoriation, crust, oozing or exudation,
- 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,
- History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics,
- 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, 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).

Criteria related to the population
- Child with a brother or sister already included in this study,
- Patient and/or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing,
- Parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship,
- Parent(s) or guardian(s) who cannot be contacted by telephone in an emergency,
- Participation to another clinical trial or being in the exclusion period of another clinical trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of V0034CR01B cream on xerosis in children with atopic dermatitis.;Secondary Objective: To document the impact of the absence and the reintroduction of emollient treatment.<br>To document the clinical (local and systemic) safety of the treatment over the study duration.<br>;Primary end point(s): Xerosis score: mean evolution over the different time-points of double-blind period D1–D28 (D7, D14, D21 and D28). ;Timepoint(s) of evaluation of this end point: D7, D14, D21 and D28

Secondary Outcome Measures

Name	Time	Method

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