Clinical Trial: Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Split-face, Paired-comparison, Pilot Study to Evaluate Safety and Efficacy of Two Topical Benzoyl Peroxide 10.0% Creams for Mild to Moderate Acne Vulgaris

Brief Summary: This study is a split face, paired-comparison, pilot study of 10 subjects. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from the clinic, as well as advertising and from previous Institutional Review Board (IRB) approved acne studies housed in the Department of Dermatology. All subjects accrued from previous studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion criteria will be eligible to participate.

Detailed Summary:

Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules).

The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diptheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne.

Topical benzoyl peroxide is a common and well-established agent with known antibacterial and antimicrobial properties used in the treatment of acne vulgaris. The safety profile for topical benzoyl peroxide has been well delineated. The most common side effects attributed to benzoyl peroxide products include irritation, dryness, scaling, burning and stinging.

Benzoyl peroxide 10.0% creams (Formulation #1 and Formulation #2) will be evaluated to detect any differences in their response for safety
Sponsor: Northwestern University

Current Primary Outcome: Number of Inflammatory Lesions (Papules and Pustules) [ Time Frame: 4 Weeks ]

Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.


Original Primary Outcome: Determine if the Formulation #1 will globally improve resolution of acne lesions by Physician Global Assessment when compared to the application of Formulation #2. [ Time Frame: 4 Weeks ]

Current Secondary Outcome:

Original Secondary Outcome: The subject's medication side effect profile will be assessed using a Application Site scale for dryness, scaling, redness, and stinging/burning. [ Time Frame: 4 Weeks ]

Information By: Northwestern University

Dates:
Date Received: November 6, 2008
Date Started: May 2008
Date Completion:
Last Updated: April 10, 2015
Last Verified: March 2015