Comparison of Two Salicylic Acid Formulations
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 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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Split-Face, Paired-Comparison, Pilot Study to Evaluate Safety and Efficacy of Two Topical Salicylic Acid 1.0% Creams for Mild to Moderate Acne Vulgaris|
- Physician Global Assessment [ Time Frame: 28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3). ] [ Designated as safety issue: No ]Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicyclic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: topical salicylic acid 1.0% cream||
Drug: Formulation A
Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily.Drug: Formulation B
Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.
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.
|United States, Illinois|
|Children's Memorial Hospital Division of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Amy Paller, MD||Children's Memorial Hospital Division of Dermatology|
|Study Director:||Dennis P West, PhD||Northwestern University Department of Dermatology|