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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Lipo Hydroxy Acid; Drug: 5% benzoyl peroxide gel

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: PanOxyl 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in inflammatory lesions	Days 28, 56 and 87

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in non-inflammatory lesions	Days 28, 56 and 87
Overall efficacy	Days 28, 56 and 87
Overall tolerance	Days 28, 56 and 87
Evaluation of pruritus, burning and tingling by the subject	Days 28, 56 and 87
Evaluation of erythema and desquamation by the blind assessor	Days 28, 56 and 87

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Collaborators: Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): September 20, 2011
• Last Update Submitted That Met QC Criteria: September 18, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Acne; benzoyl peroxide; lipophilic hydroxy acid
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Benzoyl Peroxide; Salicylic Acid; Salicylates; Benzoic Acid
• Other Study ID Numbers: LRP05021