Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Northwestern University Children's Memorial Hospital |
---|---|
Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00848744 |
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
Condition | Intervention |
---|---|
Acne Vulgaris |
Drug: topical salicylic acid 1.0% cream |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | February 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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 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 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.
Ages Eligible for Study: | 13 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects using topical or systemic medication within 14 days before the study entry, which could interfere with study assessments. This includes but is not limited to the following: anti-inflammatory drugs (e.g.
topical and systemic corticosteroids and systemic antihistamines), anti-acne drugs, topical and oral retinoids, topical antibacterial agents to the face, and any immunosuppressive drugs. Ongoing oral medications not expected to interfere with study assessments are allowed if the subject is on a stable regimen.
Responsible Party: | Northwestern University Department of Dermatology ( Amy Paller / MD ) |
Study ID Numbers: | AP-011008 |
Study First Received: | November 24, 2008 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848744 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acne |
Keratolytic Agents Anti-Infective Agents Exanthema Facial Dermatoses Skin Diseases |
Facies Antifungal Agents Salicylic Acid Sebaceous Gland Diseases Acne Vulgaris |
Keratolytic Agents Anti-Infective Agents Facial Dermatoses Skin Diseases Acneiform Eruptions Antifungal Agents |
Therapeutic Uses Salicylic Acid Sebaceous Gland Diseases Dermatologic Agents Pharmacologic Actions Acne Vulgaris |