Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00931411
Status:
TERMINATED
Last Update Posted:
2011-09-20
First Post:
2009-06-29
Brief Title:
Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis
Sponsor:
Cosmetique Active International
Organization:
Cosmetique Active International
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients would improve naturally due to weather conditions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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 parents 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 parents at D0 and D42
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 parents at D0 and D42
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCER 08-09-009 | OTHER | Comité centrale déthique de la recherche | None |