Study of Two Different 10.0% Benzoyl Peroxide Creams for Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

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.
    

Intervention name(s): Topical benzoyl peroxide 10.0% cream - Formulation 1; Topical benzoyl peroxide 10.0% cream - Formulation 2
Intervention type(s): Drug; Drug
Intervention description(s): Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.; Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Other intervention name(s): Benzoyl Peroxide 10% Cream; Benzoyl Peroxide 10% Cream
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne