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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Innate Immunity in Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Calcipotriene
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcipotriene Cream<br>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<br>* 1g daily BID<br>* Other names: Vitamin D cream;|
| Placebo Comparator: Placebo<br>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<br>* 1g daily BID<br>* Other names: Placebo cream manufactured to mimic calcipotriene;|

What is the study measuring?
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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 |