Comparison of Two Salicylic Acid Formulations
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|ClinicalTrials.gov Identifier: NCT00848744|
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 5, 2010
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Formulation A Drug: Formulation B||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
|Experimental: 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.
- Physician Global Assessment [ Time Frame: 28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3). ]Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848744
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Amy Paller, MD||Ann & Robert H Lurie Children's Hospital of Chicago|
|Study Director:||Dennis P West, PhD||Northwestern University Department of Dermatology|