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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624676
Recruitment Status : Completed
First Posted : February 27, 2008
Last Update Posted : September 20, 2011
Innovaderm Research Inc.
Information provided by (Responsible Party):
Robert BISSONNETTE, Cosmetique Active International

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Lipo Hydroxy Acid Drug: 5% benzoyl peroxide gel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reduction in inflammatory lesions [ Time Frame: Days 28, 56 and 87 ]

Secondary Outcome Measures :
  1. Reduction in non-inflammatory lesions [ Time Frame: Days 28, 56 and 87 ]
  2. Overall efficacy [ Time Frame: Days 28, 56 and 87 ]
  3. Overall tolerance [ Time Frame: Days 28, 56 and 87 ]
  4. Evaluation of pruritus, burning and tingling by the subject [ Time Frame: Days 28, 56 and 87 ]
  5. Evaluation of erythema and desquamation by the blind assessor [ Time Frame: Days 28, 56 and 87 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00624676

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Canada, Quebec
Innovaderm Research
Laval, Quebec, Canada
Innovaderm Research
Montreal, Quebec, Canada
Sponsors and Collaborators
Cosmetique Active International
Innovaderm Research Inc.
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Principal Investigator: Robert Bissonnette, MD Innovaderm Research
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Responsible Party: Robert BISSONNETTE, President and Dermatologist, Cosmetique Active International Identifier: NCT00624676    
Other Study ID Numbers: LRP05021
First Posted: February 27, 2008    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011
Keywords provided by Robert BISSONNETTE, Cosmetique Active International:
lipophilic hydroxy acid
benzoyl peroxide
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Salicylic Acid
Benzoic Acid
Benzoyl Peroxide
Dermatologic Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action