Back to results"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcipotriene
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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.
Sites / Locations
- UCLA Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Calcipotriene Cream
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01694433
First Posted
September 24, 2012
Last Updated
April 18, 2019
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT01694433
Brief Title
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Official Title
Innate Immunity in Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 9, 2014 (Actual)
Study Completion Date
January 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcipotriene Cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcipotriene
Other Intervention Name(s)
Dovonex, Vitamin D cream
Intervention Description
1g daily BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo cream manufactured to mimic calcipotriene
Intervention Description
1g daily BID
Primary Outcome Measure Information:
Title
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Description
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Time Frame
Weeks 2, 4, 8 & 12
Secondary Outcome Measure Information:
Title
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
Description
Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)
Time Frame
Weeks 2, 4, 8 & 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Kim, MD,PhD
Organizational Affiliation
UCLA Department of Medicine/Division of Dermatology and Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Dermatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
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