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

Acne Vulgaris Clinical Trial

Official title:

Innate Immunity in Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694433
• Other study ID #: 1R01AR053542-01A2
• Secondary ID: 1R01AR053542-01A
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2013
• Est. completion date: January 9, 2014

Study information

• Verified date: April 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 9, 2014
• Est. primary completion date: January 9, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Calcipotriene
1g daily BID
• Placebo
1g daily BID

Locations

Country	Name	City	State
United States	UCLA Dermatology	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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