Comparison of Two Salicylic Acid Formulations
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This study is a split face, paired-comparison, pilot study of at least 10 subjects to
      complete. 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 one of the clinics, as well as 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)1.

      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 diphtheroid
      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 acne1.

      Topical salicylic acid is a common and well-established agent with known keratolytic
      properties used in the treatment of acne vulgaris. The safety profile for topical salicylic
      acid has been well delineated. The most common side effects attributed to salicylic acid
      products include irritation, dryness, scaling, burning and stinging.

      Salicylic acid 1.0% creams (Formulation A and Formulation B) will be evaluated to detect any
      differences in their response for safety and efficacy.
    

Intervention name(s): Formulation A; Formulation B
Intervention type(s): Drug; Drug
Intervention description(s): Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily.; Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne