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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jenny Kim, MD, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01694433
First received: September 24, 2012
Last updated: October 18, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • Dovonex
  • Vitamin D cream
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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694433

Locations
United States, California
UCLA Dermatology
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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: October 18, 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
Vitamins
Calcitriol
Calcipotriene
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
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 August 28, 2014