"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on the face and on the bacteria that cause acne. The information gained from this study may lead to new treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream that looks like Calcipotriene, but contains no active ingredients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Innate Immunity in Acne Vulgaris|
- Determine the clinical efficacy of a topical vitamin D analogue for acne therapy by assessing lesion counts (total, inflammatory and non-inflammatory) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinical Global Improvement (CGI) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Calcipotriene Cream
The Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
1g daily BID
Placebo Comparator: Placebo
The Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
1g daily BID
Other Name: Placebo cream manufactured to mimic calcipotriene
This study will be a randomized, double-blinded, parallel group comparison of calcipotriene vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12 weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as calculated by power analysis. Three additional subjects for each group will be recruited for possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint (lesion count) and secondary endpoints described in aims 3.2-3.4 will be determined. Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of the lesions will be noted at each visit. Photographs will be taken to aid in assessing the clinical changes.
|Contact: Gail D Thames, BAemail@example.com|
|Contact: Alexis R Jones, NPfirstname.lastname@example.org|
|United States, California|
|Los Angeles, California, United States, 90095|
|Sub-Investigator: Christina Kim, MD|
|Principal Investigator:||Jenny Kim, MD||UCLA Department of Dermatology|