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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 : Completed
First Posted : September 27, 2012
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
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

Tracking Information
First Submitted Date  ICMJE September 24, 2012
First Posted Date  ICMJE September 27, 2012
Results First Submitted Date  ICMJE March 15, 2019
Results First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE February 2013
Actual Primary Completion Date January 9, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Lesion Counts (Total, Inflammatory and Non-inflammatory) [ Time Frame: Weeks 2, 4, 8 & 12 ]
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Acne Severity as Assessed With the Investigator's Global Assessment (IGA) [ Time Frame: Weeks 2, 4, 8 & 12 ]
Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Official Title  ICMJE Innate Immunity in Acne Vulgaris
Brief Summary The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on 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.
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 endpoint (IGA- Investigator's Global Assessment) 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Calcipotriene
    1g daily BID
    Other Names:
    • Dovonex
    • Vitamin D cream
  • Drug: Placebo
    1g daily BID
    Other Name: Placebo cream manufactured to mimic calcipotriene
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2019)
66
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2012)
54
Actual Study Completion Date  ICMJE January 9, 2014
Actual Primary Completion Date January 9, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694433
Other Study ID Numbers  ICMJE 1R01AR053542-01A2( U.S. NIH Grant/Contract )
1R01AR053542-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jenny Kim, MD, PhD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Jenny Kim, MD,PhD UCLA Department of Medicine/Division of Dermatology and Nutrition
PRS Account University of California, Los Angeles
Verification Date April 2019

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