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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lipo Hydroxy Acid

5% benzoyl peroxide gel

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, lipophilic hydroxy acid, benzoyl peroxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Innovaderm Research
Innovaderm Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

LHA formulation

5% benzoyl peroxide

Outcomes

Primary Outcome Measures

Reduction in inflammatory lesions

Secondary Outcome Measures

Reduction in non-inflammatory lesions

Overall efficacy

Overall tolerance

Evaluation of pruritus, burning and tingling by the subject

Evaluation of erythema and desquamation by the blind assessor

Full Information

NCT ID

NCT00624676

First Posted

February 19, 2008

Last Updated

September 18, 2011

Sponsor

Cosmetique Active International

Collaborators

Innovaderm Research Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00624676

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cosmetique Active International

Collaborators

Innovaderm Research Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne, lipophilic hydroxy acid, benzoyl peroxide

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

LHA formulation

Arm Title

Arm Type

Active Comparator

Arm Description

5% benzoyl peroxide

Intervention Type

Drug

Intervention Name(s)

Lipo Hydroxy Acid

Other Intervention Name(s)

Effaclar AI, 2-hydroxy 5-octanoyl benzoic acid, LHA, C8-LHA, capryloyl salicylic acid

Intervention Description

Twice a day

Intervention Type

Drug

Intervention Name(s)

5% benzoyl peroxide gel

Other Intervention Name(s)

PanOxyl 5

Intervention Description

Once a day

Primary Outcome Measure Information:

Title

Reduction in inflammatory lesions

Time Frame

Days 28, 56 and 87

Secondary Outcome Measure Information:

Title

Reduction in non-inflammatory lesions

Time Frame

Days 28, 56 and 87

Title

Overall efficacy

Time Frame

Days 28, 56 and 87

Title

Overall tolerance

Time Frame

Days 28, 56 and 87

Title

Evaluation of pruritus, burning and tingling by the subject

Time Frame

Days 28, 56 and 87

Title

Evaluation of erythema and desquamation by the blind assessor

Time Frame

Days 28, 56 and 87

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Bissonnette, MD

Organizational Affiliation

Innovaderm Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Innovaderm Research

City

Laval

State/Province

Quebec

Country

Canada

Facility Name

Innovaderm Research

City

Montreal

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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