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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
Sponsor study identifier
Secondary identifiers
OTHER · Comité centrale d'éthique de la recherche
interventional
73
1 country
5
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
July 2009
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 2009
Actual (reported)June 29, 2009
Actual (reported)July 2009
Actual (reported)July 2, 2009
Actual (reported)February 3, 2011
Actual (reported)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
Change in Mean Global Efficacy (by Investigator).
7, 42 Days
Change in Mean Global Efficacy (by Parent)
7, 42 days
Change in Mean Quality of Life
0, 42 days
Change in Mean Cosmetic Acceptability Before Crossover
0, 42 days
Change in Mean Cosmetic Acceptability After Crossover
14 days (Day 42 to Day 56 of the study)
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.
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.
Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
Moisturizer, applied topically to whole body, twice a day, morning and evening, after bathing.
The Guenther Dermatology Research Center
London, Ontario, Canada
Lynderm Research
Markham, Ontario, Canada
Innovaderm Research Inc
Laval, Quebec, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Centre de recherche dermatologique du Québec Métropolitain
Québec, Quebec, Canada
Robert Bissonnette, MD
Innovaderm Research
73 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2009
First Posted
July 2, 2009
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
September 20, 2011
Results First Posted
February 3, 2011
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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