Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis

Double-Blind Study of Tolerance and Moisturizers Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis Under Normal Conditions of Use

Atopic dermatitis is one of the most frequent skin diseases. The disease is often worst during winter months when the skin is drier. Mild to moderate cases of atopic dermatitis are often controlled by a moisturizer alone. The use of moisturizers has been shown to have beneficial effects on atopic dermatitis. It can break the dry skin cycle by hydrating the upper layer of the skin which may prevent the recurrence of the disease and can reduce the use of cream or ointment medications such as corticosteroids. Formulation 609580 20 was developed to keep the moisturizing efficacy of formulation 609209 but to improve its tolerance and cosmetic acceptability (easier to apply, nicer texture, etc.). The new formulation contains the same quantity of shea butter and glycerin but in a different excipient (inactive substance) than the commercial product. In addition, vitamin B3 was added to see if it could help in reducing itching.

The purpose of this study is to determine the safety and efficacy of two study products in children with atopic dermatitis. One of the study products (formulation 609580 20) is not commercially available (outside of clinical trials such as this one). The other study product (formulation 609209) has been approved in Canada and is currently available commercially under the trade name Lipikar Baume.

For this study the child will be randomly assigned to one of the following two groups:

• Group 1: 50 children will receive formulation 609209, the commercial formula for 42 days and will receive formulation 609580 20, the new formula, for 14 days.
• Group 2: 50 children will receive formulation 609580 20, the new formula, for 42 days and will receive formulation 609209, the commercial formula, for 14 days.

A randomized clinical trial performed at five (5) centers (Montreal, Laval, Quebec City, (Quebec); Markham, London (Ontario), Canada). One hundred (100) patients are enrolled in the study. Subjects and parent(s) or guardian are asked to present to the clinic for five (5) visits (Screening, D0, D7, D42, D56). Formulation 609580 20 or 609209 is applied twice a day (morning and evening) to the whole body for a total of 42 days and then there is a crossover between the two formulations.

Efficacy is evaluated at D0, D7 and D42 measured by SCORAD (scoring atopic dermatitis). Tolerance is evaluated by the investigator at D7, D42 and D56. Global efficacy is measured by parents and investigator at D7 and D42. Medical photographs (optional) of lesions are taken with patients consent at D0 and D42. A crossover between the two products occurs at day 42 so that cosmetic acceptability can be compared at D42 and D56. Skin examinations are performed at all visits. A quality of life questionnaire is filled out by the parent(s) at D0 and D42.

Inclusion Criteria:

• 3-12 years of age
• Suffering from a mild to moderate atopic dermatitis that is amenable to treatment with moisturizer only
• SCORAD (scoring atopic dermatitis) of 10-30 at screening and Day 0
• Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features; please refer to appendix D)
• Atopic dermatitis has been, in the opinion of the investigator, stable for the past 28 days
• Subject with parents able to apply the study product twice a day (each morning and evening) for a 56 days period
• Subject with parents agreeing not to change their child's lifestyle during the study period (including their usual body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash the child's clothes)
• Subject with parents agreeing that their child uses only the test product as body emollient on the whole body during the study period
• Subject with parents available to completely follow the study with their child
• Subject with parents able and willing to sign the informed consent form and to comply with the study regulations of this protocol

Exclusion Criteria:

• Subject has another dermatological condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
• Subject has a previous history of allergy to cosmetic products or any ingredients of the tested formulations
• Subject has received any systemic treatment, including PUVA (psoralen ultraviolet A) therapy for atopic dermatitis within 28 days prior to screening
• Subject has received any topical immunomodulators for atopic dermatitis (such as pimecrolimus or tacrolimus) within 14 days of Day 0
• Subject has received phototherapy within 14 days of Day 0
• Subject intends to expose him/herself to the sun during the trial
• Subject has known allergy to any component of tested products
• Subject has used any experimental treatment within 14 days of Day 0
• Subject has used any topical corticosteroid of class I-IV within 14 days of Day 0