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

NCT ID: NCT01694433

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-01-09

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Calcipotriene

Intervention Type: DRUG

1g daily BID

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1g daily BID

Interventions

Calcipotriene

1g daily BID

Intervention Type: DRUG

Placebo

1g daily BID

Intervention Type: DRUG

Other Intervention Names

Dovonex; Vitamin D cream; Placebo cream manufactured to mimic calcipotriene

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Jenny Kim, MD, PhD

Professor of Medicine/Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA Department of Medicine/Division of Dermatology and Nutrition

Locations

UCLA Dermatology

Los Angeles, California, United States

Countries

United States

Other Identifiers

1R01AR053542-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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1R01AR053542-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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