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

Sponsor:	Cosmetique Active International
Collaborator:	Innovaderm Research Inc.
Information provided by (Responsible Party):	Robert BISSONNETTE, Cosmetique Active International
ClinicalTrials.gov Identifier:	NCT00624676

Purpose

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	Intervention
Acne Vulgaris	Drug: Lipo Hydroxy Acid Drug: 5% benzoyl peroxide gel

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoic acid Salicylic acid Benzoyl peroxide

U.S. FDA Resources

Further study details as provided by Cosmetique Active International:

Primary Outcome Measures:

Reduction in inflammatory lesions [ Time Frame: Days 28, 56 and 87 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	80
Study Start Date:	January 2006
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A LHA formulation	Drug: Lipo Hydroxy Acid Twice a day Other Names: Effaclar AI 2-hydroxy 5-octanoyl benzoic acid LHA C8-LHA capryloyl salicylic acid
Active Comparator: B 5% benzoyl peroxide	Drug: 5% benzoyl peroxide gel Once a day Other Name: PanOxyl 5

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624676

Locations

Canada, Quebec
Innovaderm Research
Laval, Quebec, Canada
Innovaderm Research
Montreal, Quebec, Canada

Sponsors and Collaborators

Cosmetique Active International

Innovaderm Research Inc.

Investigators

Principal Investigator:

Robert Bissonnette, MD

Innovaderm Research

More Information

No publications provided

Responsible Party:	Robert BISSONNETTE, President and Dermatologist, Cosmetique Active International
ClinicalTrials.gov Identifier:	NCT00624676 History of Changes
Other Study ID Numbers:	LRP05021
Study First Received:	February 19, 2008
Last Updated:	September 18, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Cosmetique Active International:

Acne
lipophilic hydroxy acid
benzoyl peroxide

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Salicylic Acid

Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on February 09, 2012