Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cosmetique Active International
• Collaborator: Innovaderm Research Inc.
• Treatments: Benzoic Acid; Benzoyl Peroxide; Salicylates; Salicylic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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