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

NCT00624676 | Completed

• 1 other identifier: LRP05021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Keywords

Acne; lipophilic hydroxy acid; benzoyl peroxide

Outcome Measures

Primary Outcomes (1)

• Reduction in inflammatory lesions

  Days 28, 56 and 87

Secondary Outcomes (5)

• 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

Study Arms (2)

A

EXPERIMENTAL

LHA formulation

Drug: Lipo Hydroxy Acid

B

ACTIVE COMPARATOR

5% benzoyl peroxide

Drug: 5% benzoyl peroxide gel

Interventions

Lipo Hydroxy Acid DRUG

Twice a day

Also known as: Effaclar AI, 2-hydroxy 5-octanoyl benzoic acid, LHA, C8-LHA, capryloyl salicylic acid

A

5% benzoyl peroxide gel DRUG

Once a day

Also known as: PanOxyl 5

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cosmetique Active International: lead
• Innovaderm Research Inc.: collaborator

Study Sites (2)

Innovaderm Research

Laval, Quebec, Canada

Location

Innovaderm Research

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

capryloyl salicylic acid; Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Dermatologist

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: January 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

CA (2)