Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

Will be eligible patients who meet the following criteria:
- Age between 2 and 7 years,
- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party,
- Whose IGA score is < or = 1 at inclusion,
- Whose parent(s) or guardian(s) has(have) 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,
- If required by national regulations, registered with a social security or health insurance system.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Will not be included patients who have one of the following criteria:
* Criteria related to pathologies
- Acute phase of atopic dermatitis with mild/moderate/severe erythema, excoriation, crust, oozing, exudation,
- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- Dermatological disease other than atopic dermatitis liable to interfere with the assessment,
- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study,
- Immunosuppression,
- History of allergy or intolerance to the study drug or its excipients, or to cosmetics.
* Criteria related to treatments
- Use of oral corticosteroids or immunosuppressants during the last month,
- Use of antibiotics or topical corticosteroids during the last week,
- Use of non-steroid anti-inflammatory drugs or antihistamines during the last week,
- Use of homeopathic treatment during the last 2 months,
- Regular use of food supplements that could, in the opinion of the investigator, modify skin properties.
* 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

Secondary Outcome Measures

Name	Time	Method

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