Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris
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 such as benzoyl peroxide, retinoids and antibiotics. These treatments can be associated with local tolerance problems and/or antibiotic resistance. Salicylic acid has been shown to be an effective treatment for acne. LHA is a lipophilic hydroxy acid derivative of salicylic acid that has comedolytic and antibacterial properties.
The objective of this trial was to compare the efficacy and tolerance of a cream formulation containing 0.3% LHA (LHA formulation) to a 5% benzoyl peroxide gel.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Study Comparing the Efficacy and Tolerance of a Lipophilic Hydroxy Acid Derivative of Salicylic Acid and 5% Benzoyl Peroxide in the Treatment of Facial Acne Vulgaris|
- Reduction in inflammatory lesions [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: No ]
- Reduction in non-inflammatory lesions [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: No ]
- Overall efficacy [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: No ]
- Overall tolerance [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: Yes ]
- Evaluation of pruritus, burning and tingling by the subject [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: Yes ]
- Evaluation of erythema and desquamation by the blind assessor [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Drug: Lipo Hydroxy Acid
Twice a day
Active Comparator: B
5% benzoyl peroxide
Drug: 5% benzoyl peroxide gel
Once a day
Other Name: PanOxyl 5
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 study. Subjects were asked to report to the clinic for four visits (D0, D28, D56, D87). The LHA formulation was applied twice a day (morning and evening) and benzoyl peroxide was applied daily (evening) on a clean face for a total of 12 weeks.
Efficacy was evaluated at day 28, 56 and 87. The number of papules, pustules, opened and closed comedones were counted at each visit by a blinded assessor. The overall efficacy was evaluated with a 4-point scale (no improvement, moderate, good and excellent) by the subject and the blinded assessor. Clinical examination included evaluation of sensitivity of the skin (presence of erythema and desquamation) by the investigator and of pruritus, tingling and burning sensation by subjects on a 4-point scale. Finally, the subject and the skin assessor both evaluated overall tolerance on a 4-point scale.
|Laval, Quebec, Canada|
|Montreal, Quebec, Canada|
|Principal Investigator:||Robert Bissonnette, MD||Innovaderm Research|