Status:
TERMINATED
Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis
Lead Sponsor:
Cosmetique Active International
Collaborating Sponsors:
Innovaderm Research Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3-12 years
Phase:
NA
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...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00931411
Start Date
January 1 2009
End Date
July 1 2009
Last Update
September 20 2011
Active Locations (5)
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1
The Guenther Dermatology Research Center
London, Ontario, Canada
2
Lynderm Research
Markham, Ontario, Canada
3
Innovaderm Research Inc
Laval, Quebec, Canada
4
Innovaderm Research Inc
Montreal, Quebec, Canada