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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR053542-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriene Cream | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene | Drug | 1g daily BID |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Kim, MD,PhD | UCLA Department of Medicine/Division of Dermatology and Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Dermatology | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcipotriene Cream | The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Calcipotriene: 1g daily BID |
| FG001 | Placebo | The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Placebo: 1g daily BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One enrolled participant withdrew from the Placebo arm prior to Baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcipotriene Cream | The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Calcipotriene: 1g daily BID |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lesion Counts (Total, Inflammatory and Non-inflammatory) | Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. | The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit. | Posted | Mean | Full Range | Lesions | Weeks 2, 4, 8 & 12 |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcipotriene Cream | The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Calcipotriene: 1g daily BID |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jenny Kim | UCLA | 310-825-5420 | jekim@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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| Placebo | Drug | 1g daily BID |
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| Withdrawal by Subject |
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The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.
Placebo: 1g daily BID
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Inflammatory Lesion Count | Mean | Full Range | Lesions |
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| Non-inflammatory Lesion Count | Mean | Full Range | Lesions |
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| Total Lesion Count | Mean | Full Range | Lesions |
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| IGA at Baseline | Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe) | Mean | Full Range | score on a scale |
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| 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) | The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit. | Posted | Mean | Full Range | score on a scale | Weeks 2, 4, 8 & 12 |
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| 0 |
| 33 |
| 0 |
| 33 |
| 18 |
| 33 |
| EG001 | Placebo | The Placebo Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks. Placebo: 1g daily BID | 0 | 32 | 0 | 32 | 19 | 32 |
| Allergic reaction | Immune system disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bug bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bump on eyelid | Eye disorders | Systematic Assessment |
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| Common cold/allergy | Infections and infestations | Systematic Assessment |
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| Facial dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flu-like symptoms | General disorders | Systematic Assessment |
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| Menstrual cramps | Reproductive system and breast disorders | Systematic Assessment |
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| GI Flu | Gastrointestinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Facial irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sore Throat | General disorders | Systematic Assessment |
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| IGA at Week 4 |
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| IGA at Week 8 |
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| IGA at Week 12 |
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