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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01694433
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 11.2
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Calcipotriene; Drug: Placebo	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Innate Immunity in Acne Vulgaris
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jan 9, 2014
• Actual Study Completion Date: Jan 9, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Calcipotriene; 1g daily BID; Other Names: Dovonex Vitamin D cream
Placebo Comparator: 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.	Drug: Placebo; 1g daily BID; Other Names: Placebo cream manufactured to mimic calcipotriene

Outcome Measures

Primary Outcome Measures

1. Lesion Counts (Total, Inflammatory and Non-inflammatory) [Weeks 2, 4, 8 & 12]

   Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.

Secondary Outcome Measures

1. Acne Severity as Assessed With the Investigator's Global Assessment (IGA) [Weeks 2, 4, 8 & 12]

   Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Dermatology	Los Angeles	California	United States	90095

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jenny Kim, MD,PhD, UCLA Department of Medicine/Division of Dermatology and Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jenny Kim, MD, PhD, Professor of Medicine/Dermatology, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01694433
• Other Study ID Numbers: 1R01AR053542-01A2; 1R01AR053542-01A2
• First Posted: Sep 27, 2012
• Last Update Posted: May 7, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Additional relevant MeSH terms: Acne Vulgaris; Vitamin D; Calcitriol; Calcipotriene

Study Results

Participant Flow

Arm/Group Title	Calcipotriene Cream	Placebo
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	33	33
Baseline Visit	33	32
COMPLETED	22	29
NOT COMPLETED	11	4

Baseline Characteristics

Arm/Group Title	Calcipotriene Cream	Placebo	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	33	32	65
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 100%	32 100%	65 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	22 66.7%	22 68.8%	44 67.7%
Male	11 33.3%	10 31.3%	21 32.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 18.2%	8 25%	14 21.5%
Not Hispanic or Latino	27 81.8%	24 75%	51 78.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	13 39.4%	15 46.9%	28 43.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 6.1%	1 3.1%	3 4.6%
White	18 54.5%	16 50%	34 52.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	33 100%	32 100%	65 100%
Inflammatory Lesion Count (Lesions) [Mean (Full Range) ]
Mean (Full Range) [Lesions]	16.8	11.7	14.3
Non-inflammatory Lesion Count (Lesions) [Mean (Full Range) ]
Mean (Full Range) [Lesions]	48.4	38.4	43.5
Total Lesion Count (Lesions) [Mean (Full Range) ]
Mean (Full Range) [Lesions]	67.3	50.1	57.8
IGA at Baseline (score on a scale) [Mean (Full Range) ]
Mean (Full Range) [score on a scale]	3.15	3.06	3.11

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.

Arm/Group Title	Calcipotriene Cream	Placebo
Arm/Group Description	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	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
Measure Participants	33	32
Inflammatory lesions at Week 2	18.4	13.4
Inflammatory lesions at Week 4	15.8	9.9
Inflammatory lesions at Week 8	12.1	10.2
Inflammatory lesions at Week 12	10.5	7.0
Non-inflammatory lesions at Week 2	30.9	33.1
Non-inflammatory lesions at Week 4	35.5	34.4
Non-inflammatory lesions at Week 8	22.1	24.3
Non-inflammatory lesions at Week 12	19.6	20.2
Total lesions at Week 2	51.0	46.5
Total lesions at Week 4	51.4	44.3
Total lesions at Week 8	34.2	34.55
Total lesions at Week 12	30.1	27.24

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.

Arm/Group Title	Calcipotriene Cream	Placebo
Arm/Group Description	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	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
Measure Participants	33	32
IGA at Week 2	2.77	2.9
IGA at Week 4	2.83	2.59
IGA at Week 8	2.21	2.48
IGA at Week 12	2.23	2.31

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Calcipotriene Cream		Placebo
Arm/Group Description	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		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
All Cause Mortality
	Calcipotriene Cream		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/32 (0%)
Serious Adverse Events
	Calcipotriene Cream		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Calcipotriene Cream		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/33 (54.5%)		19/32 (59.4%)
Eye disorders
Bump on eyelid	0/33 (0%)	0	1/32 (3.1%)	1
Gastrointestinal disorders
GI Flu	1/33 (3%)	1	0/32 (0%)	0
General disorders
Flu-like symptoms	1/33 (3%)	1	2/32 (6.3%)	2
Headache	0/33 (0%)	0	2/32 (6.3%)	3
Insomnia	1/33 (3%)	1	0/32 (0%)	0
Sore Throat	0/33 (0%)	0	2/32 (6.3%)	2
Immune system disorders
Allergic reaction	1/33 (3%)	1	1/32 (3.1%)	1
Infections and infestations
Infection	0/33 (0%)	0	2/32 (6.3%)	2
Common cold/allergy	10/33 (30.3%)	11	7/32 (21.9%)	8
Reproductive system and breast disorders
Menstrual cramps	1/33 (3%)	1	1/32 (3.1%)	3
Skin and subcutaneous tissue disorders
Acne	4/33 (12.1%)	4	2/32 (6.3%)	2
Bruising	1/33 (3%)	1	0/32 (0%)	0
Bug bite	1/33 (3%)	1	0/32 (0%)	0
Facial dryness	18/33 (54.5%)	22	5/32 (15.6%)	5
Hives	0/33 (0%)	0	1/32 (3.1%)	1
Facial irritation	5/33 (15.2%)	5	2/32 (6.3%)	2
Itching	1/33 (3%)	1	2/32 (6.3%)	2
Rash	1/33 (3%)	1	2/32 (6.3%)	2
Redness	7/33 (21.2%)	7	2/32 (6.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.