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

Information source: Cosmetique Active International
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Lipo Hydroxy Acid (Drug); 5% benzoyl peroxide gel (Drug)

Phase: N/A

Status: Completed

Sponsored by: Cosmetique Active International

Official(s) and/or principal investigator(s):
Robert Bissonnette, MD, Principal Investigator, Affiliation: Innovaderm Research


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in inflammatory lesions

Secondary outcome:

Reduction in non-inflammatory lesions

Overall efficacy

Overall tolerance

Evaluation of pruritus, burning and tingling by the subject

Evaluation of erythema and desquamation by the blind assessor

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 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Innovaderm Research, Laval, Quebec, Canada

Innovaderm Research, Montreal, Quebec, Canada

Additional Information

Starting date: January 2006
Last updated: September 18, 2011

Page last updated: August 23, 2015

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