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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Calcipotriene Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Innate Immunity in Acne Vulgaris
Study Start Date : February 2013
Actual Primary Completion Date : January 9, 2014
Actual Study Completion Date : January 9, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694433


Locations
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United States, California
UCLA Dermatology
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Jenny Kim, MD,PhD UCLA Department of Medicine/Division of Dermatology and Nutrition
More Information
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Responsible Party: Jenny Kim, MD, PhD, Professor of Medicine/Dermatology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01694433    
Other Study ID Numbers: 1R01AR053542-01A2 ( U.S. NIH Grant/Contract )
1R01AR053542-01A2 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2012    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Vitamin D
Calcitriol
Calcipotriene
Vitamins
Micronutrients
Nutrients
 Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents