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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Other: Formulation 609580 20
  • Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
• Other: Formulation 609209 (Lipikar Baume)
  • Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Formulation 609580 20 then 609209
  • Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
• Active Comparator: Formulation 609209 then 609580 20
  • Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.

Primary Measures

• Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0
  • Time Frame: 7 , 42 days
    Safety Issue?: No

Secondary Measures

• Change in Mean Global Efficacy (by Investigator).
  • Time Frame: 7, 42 Days
    Safety Issue?: No
• Change in Mean Global Efficacy (by Parent)
  • Time Frame: 7, 42 days
    Safety Issue?: No
• Change in Mean Quality of Life
  • Time Frame: 0, 42 days
    Safety Issue?: No
• Change in Mean Cosmetic Acceptability Before Crossover
  • Time Frame: 0, 42 days
    Safety Issue?: No
• Change in Mean Cosmetic Acceptability After Crossover
  • Time Frame: 14 days (Day 42 to Day 56 of the study)
    Safety Issue?: No
• Change in Tolerance Before Crossover
  • Time Frame: 7, 42 days
    Safety Issue?: Yes
• Change in Mean Tolerance After Crossover
  • Time Frame: 14 Days (Day 42 to Day 56 of the study)
    Safety Issue?: No
• Preferred Formulation
  • Time Frame: 56 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Cosmetique Active International Industry

Overall Clinical Trial Officials and Contacts

Robert Bissonnette, MD Principal Investigator Innovaderm Research  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931411

Study ID Number: LRP07019

ClinicalTrials.gov Identifier: NCT00931411

Health Authority: Canada: Ethics Review Committee