Status:
COMPLETED
Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris
Lead Sponsor:
Cosmetique Active International
Collaborating Sponsors:
Innovaderm Research Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acne vulgaris is a frequent inflammatory skin condition involving the pilosebaceous unit and affecting more than 80% of teenagers. Mild to moderate acne vulgaris is usually treated with topical agents...
Detailed Description
This was a randomized clinical trial performed at two centers (Montreal and Laval, Quebec, Canada) under the direction of the same principal investigator. Eighty (80) subjects were enrolled in the stu...
Eligibility Criteria
Inclusion
- 18 years old or older
- Phototype greater than I
- Facial inflammatory acne with 15-50 inflammatory lesions and less than 50 non-inflammatory lesions (excluding the nasal pyramid)
- Did not receive a topical acne treatment in the last 15 days
- Did not receive cyclins or zinc-based treatment in the last month
- Did not take Diane-35 in the last 2 months. Current use of oral contraceptives is acceptable if the subject is on a stable dose for at least six months prior Day 0.
- Did not take oral isotretinoin for the last 12 months
- Did not change their cosmetic habits in the last 15 days (ex: shaving cream)
- Agree to participate to the entire study
Exclusion
- Less than 18 years old
- Phototype I
- With less than 15 or more than 50 inflammatory lesions on the face (excluding the nasal pyramid)
- With more than 50 non-inflammatory lesions on the face (excluding the nasal pyramid)
- Have taken 1) A topical acne treatment in the last 15 days, or 2) Cyclins or zinc-based treatment in the last month or 3) Oral isotretinoin in the last 12 months
- Woman: 1) Taking Diane-35, or 2) Taking an oral contraceptive for less than 6 months or 3) That are pregnant or 4) That are nursing or 5) Not using any efficient contraception method (if necessary)
- With a history of allergic reaction or hypersensitivity to one of the constituents of the study product
- With peroxide sensitivity
- With history of photosensitivity
- With history of major medical or psychiatric condition or surgical interventions that, in the opinion of the investigator, might put the subject at risk
- With an acute or chronic disease that could interfere with study results
- Susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face
- With a dermatologic condition on the face other than acne that might put the subject at risk or interfere with study evaluations
- Using another cosmetic product than the one received for this study. Sunscreens are allowed occasionally.
- Subject who must have extensive sun or ultra-violet exposure
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00624676
Start Date
January 1 2006
End Date
August 1 2006
Last Update
September 20 2011
Active Locations (2)
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1
Innovaderm Research
Laval, Quebec, Canada
2
Innovaderm Research
Montreal, Quebec, Canada