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"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"

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ClinicalTrials.gov Identifier: NCT01694433
Recruitment Status : Unknown
Verified February 2013 by Jenny Kim, MD, PhD, University of California, Los Angeles.
Recruitment status was:  Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : October 21, 2013
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Jenny Kim, MD, PhD, University of California, Los Angeles

September 24, 2012
September 27, 2012
October 21, 2013
February 2013
January 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01694433 on ClinicalTrials.gov Archive Site
Clinical Global Improvement (CGI) score [ Time Frame: 12 weeks ]
Clinical Global Improvement (CGI) score; the expression of inflammatory mediators, P. acnes count; levels of antimicrobial peptides LL-37 and DEFB4 at the site of disease will be determined in acne patients and compared to normal sub [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Innate Immunity in Acne Vulgaris
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: Calcipotriene
    1g daily BID
    Other Names:
    • Dovonex
    • Vitamin D cream
  • Drug: Placebo
    1g daily BID
    Other Name: Placebo cream manufactured to mimic calcipotriene
  • 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.
    Intervention: Drug: Calcipotriene
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
54
Same as current
December 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 years or older, of either gender and any racial/ethnic group
  2. Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
  3. Subjects must understand and sign the informed consent prior to participation
  4. Subjects must be in generally good health
  5. Subjects must be able and willing to comply with the requirements of the protocol

Exclusion Criteria:

  1. Oral retinoid use within twelve months of entry into the study
  2. Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
  3. Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
  4. Non-compliant patients
  5. Pregnant or nursing women
  6. Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation
  7. Subjects with hypercalcemia (hyperparathyroidism, kidney disease)
  8. Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01694433
1R01AR053542-01A2( U.S. NIH Grant/Contract )
1R01AR053542-01A2 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Jenny Kim, MD, PhD, University of California, Los Angeles
University of California, Los Angeles
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Jenny Kim, MD UCLA Department of Dermatology
University of California, Los Angeles
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP