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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Formulation 609580 20
* Other: Formulation 609209 (Lipikar Baume)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation 609580 20 then 609209<br>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. | Other: Formulation 609580 20<br>* Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.<br>Other: Formulation 609209 (Lipikar Baume)<br>* Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.<br>* Other names: Lipikar Baume;|
| Active Comparator: Formulation 609209 then 609580 20<br>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. | Other: Formulation 609580 20<br>* Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.<br>Other: Formulation 609209 (Lipikar Baume)<br>* Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.<br>* Other names: Lipikar Baume;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0 | The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103. | 7 , 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Global Efficacy (by Investigator). | The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator). 0 = worsening 1 = No change 2 = Mild Improvement 3 = Moderate Improvement 4 = Good Improvement 5 = Excellent Improvement | 7, 42 Days | 
| Change in Mean Global Efficacy (by Parent) | The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent). 0 = worsening 1 = No change 2 = Mild Improvement 3 = Moderate Improvement 4 = Good Improvement 5 = Excellent Improvement | 7, 42 days | 
| Change in Mean Quality of Life | The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best). | 0, 42 days | 
| Change in Mean Cosmetic Acceptability Before Crossover | The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best). | 0, 42 days | 
| Change in Mean Cosmetic Acceptability After Crossover | The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study. | 14 days (Day 42 to Day 56 of the study) | 
| Change in Tolerance Before Crossover | Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale: 1) Very good tolerance: no objective or subjective intolerance during the study 2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign 3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign 4) Poor tolerance: symptoms requiring cessation of application, no objective sign 5) Very poor tolerance: objective signs of irritative or allergic dermatitis | 7, 42 days | 
| Change in Mean Tolerance After Crossover | Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study): 1) Very good tolerance: no objective or subjective intolerance during the study 2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign 3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign 4) Poor tolerance: symptoms requiring cessation of application, no objective sign 5) Very poor tolerance: objective signs of irritative or allergic dermatitis | 14 Days (Day 42 to Day 56 of the study) | 
| Preferred Formulation | Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered. | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Vitamin B3