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

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.
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Drug: Calcipotriene
1g daily BID
Other Names:
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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.
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Drug: Placebo
1g daily BID
Other Name: Placebo cream manufactured to mimic calcipotriene |
- 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.
- 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)

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

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
United States, California | |
UCLA Dermatology | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Jenny Kim, MD,PhD | UCLA Department of Medicine/Division of Dermatology and Nutrition |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
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 |