Clinical trial NCT00787943
Conditions: Acne Vulgaris
Keywords: Acne
Sponsor: Northwestern University
Start date: 2008-05-01; Completion date: 2009-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 description:
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 and efficacy.

Arms: arm 1: Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to left side of the face. arm 2: Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to right side of the face.
Interventions: intervention 1: Topical benzoyl peroxide 10.0% cream - Formulation 1 intervention 2: Topical benzoyl peroxide 10.0% cream - Formulation 2
Intervention descriptions: intervention 1: Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily. intervention 2: Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.

Protocol documents: