Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT00624676|
Recruitment Status : Completed
First Posted : February 27, 2008
Last Update Posted : September 20, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Lipo Hydroxy Acid Drug: 5% benzoyl peroxide gel||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
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
- Reduction in inflammatory lesions [ Time Frame: Days 28, 56 and 87 ]
- Reduction in non-inflammatory lesions [ Time Frame: Days 28, 56 and 87 ]
- Overall efficacy [ Time Frame: Days 28, 56 and 87 ]
- Overall tolerance [ Time Frame: Days 28, 56 and 87 ]
- Evaluation of pruritus, burning and tingling by the subject [ Time Frame: Days 28, 56 and 87 ]
- Evaluation of erythema and desquamation by the blind assessor [ Time Frame: Days 28, 56 and 87 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624676
|Laval, Quebec, Canada|
|Montreal, Quebec, Canada|
|Principal Investigator:||Robert Bissonnette, MD||Innovaderm Research|