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

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

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 27, 2008
Last Update Posted Date September 20, 2011
Study Start Date  ICMJE January 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
Reduction in inflammatory lesions [ Time Frame: Days 28, 56 and 87 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerance of a Derivative of Salicylic Acid and 5% Benzoyl Peroxide in Facial Acne Vulgaris
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: A
    LHA formulation
    Intervention: Drug: Lipo Hydroxy Acid
  • Active Comparator: B
    5% benzoyl peroxide
    Intervention: Drug: 5% benzoyl peroxide gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2008)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624676
Other Study ID Numbers  ICMJE LRP05021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert BISSONNETTE, Cosmetique Active International
Study Sponsor  ICMJE Cosmetique Active International
Collaborators  ICMJE Innovaderm Research Inc.
Investigators  ICMJE
Principal Investigator: Robert Bissonnette, MD Innovaderm Research
PRS Account Cosmetique Active International
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP