"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 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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Calcipotriene; Drug: Placebo

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: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Placebo cream manufactured to mimic calcipotriene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Counts (Total, Inflammatory and Non-inflammatory)	Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.	Weeks 2, 4, 8 & 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)	Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)	Weeks 2, 4, 8 & 12

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Jenny Kim, MD,PhD, UCLA Department of Medicine/Division of Dermatology and Nutrition

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): January 9, 2014
• Study Completion (Actual): January 9, 2014

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Vitamin D; Calcipotriene; Calcitriol
• Other Study ID Numbers: 1R01AR053542-01A2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes