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

• ClinicalTrials.gov Identifier: NCT00624676
• Recruitment Status: Completed
• First Posted: February 27, 2008
• Last Update Posted: September 20, 2011
• Sponsor: Cosmetique Active International
• Collaborator: Innovaderm Research Inc.
• Information provided by (Responsible Party): Robert BISSONNETTE, Cosmetique Active International

Tracking Information

• First Submitted Date: February 19, 2008
• First Posted Date: February 27, 2008
• Last Update Posted Date: September 20, 2011
• Study Start Date: January 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 26, 2008): Reduction in inflammatory lesions [ Time Frame: Days 28, 56 and 87 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2008)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• Drug: Lipo Hydroxy Acid
  Twice a day
  Other Names:

  • Effaclar AI
  • 2-hydroxy 5-octanoyl benzoic acid
  • LHA
  • C8-LHA
  • capryloyl salicylic acid
• Drug: 5% benzoyl peroxide gel
  Once a day
  Other Name: PanOxyl 5

Study Arms

• Experimental: A
  LHA formulation
  Intervention: Drug: Lipo Hydroxy Acid
• Active Comparator: B
  5% benzoyl peroxide
  Intervention: Drug: 5% benzoyl peroxide gel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 26, 2008): 80
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00624676
• Other Study ID Numbers: LRP05021
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Robert BISSONNETTE, Cosmetique Active International
• Study Sponsor: Cosmetique Active International
• Collaborators: Innovaderm Research Inc.

Investigators

• Principal Investigator: Robert Bissonnette, MD; Innovaderm Research

• PRS Account: Cosmetique Active International
• Verification Date: September 2011