"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Calcipotriene Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 54 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Calcipotriene
1g daily BID
Other Names:
|
|
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.
|
Drug: Placebo
1g daily BID
Other Name: Placebo cream manufactured to mimic calcipotriene
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18 years or older, of either gender and any racial/ethnic group
- Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
- Subjects must understand and sign the informed consent prior to participation
- Subjects must be in generally good health
- Subjects must be able and willing to comply with the requirements of the protocol
Exclusion Criteria:
- Oral retinoid use within twelve months of entry into the study
- Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
- Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
- Non-compliant patients
- Pregnant or nursing women
- Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation
- Subjects with hypercalcemia (hyperparathyroidism, kidney disease)
- Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
Contacts and Locations| Contact: Gail D Thames, BA | 310-825-0453 | gthames@mednet.ucla.edu |
| Contact: Alexis R Jones, NP | 310-825-5517 | ajones@mednet.ucla.edu |
| United States, California | |
| UCLA Dermatology | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Sub-Investigator: Christina Kim, MD | |
| Principal Investigator: | Jenny Kim, MD | UCLA Department of Dermatology |
More Information
No publications provided
| Responsible Party: | Jenny Kim, MD, PhD, Associate Professor of Medicine/Dermatology, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01694433 History of Changes |
| Other Study ID Numbers: | 1 RO1 AR053542-01A2, 1R01AR053542-01A2 |
| Study First Received: | September 24, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Vitamin D Calcitriol Vitamins Calcipotriene Bone Density Conservation Agents Physiological Effects of Drugs |
Pharmacologic Actions Micronutrients Growth Substances Dermatologic Agents Therapeutic Uses Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013