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

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ClinicalTrials.gov Identifier: NCT01694433
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Jenny Kim, MD, PhD, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Calcipotriene
Drug: Placebo
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcipotriene Cream Placebo
Hide 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
Reason Not Completed
Adverse Event             7             0
Physician Decision             1             0
Withdrawal by Subject             3             4
Arm/Group Title Calcipotriene Cream Placebo Total
Hide 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 Number of Baseline Participants 33 32 65
Hide Baseline Analysis Population Description
One enrolled participant withdrew from the Placebo arm prior to Baseline
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
32
 100.0%
65
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Female
22
  66.7%
22
  68.8%
44
  67.7%
Male
11
  33.3%
10
  31.3%
21
  32.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Hispanic or Latino
6
  18.2%
8
  25.0%
14
  21.5%
Not Hispanic or Latino
27
  81.8%
24
  75.0%
51
  78.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
American Indian or Alaska Native
0
   0.0%
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%
0
   0.0%
Black or African American
2
   6.1%
1
   3.1%
3
   4.6%
White
18
  54.5%
16
  50.0%
34
  52.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 32 participants 65 participants
33 32 65
Inflammatory Lesion Count  
Mean (Full Range)
Unit of measure:  Lesions
Number Analyzed 33 participants 32 participants 65 participants
16.8
(0 to 59)
11.7
(1 to 34)
14.3
(1 to 59)
Non-inflammatory Lesion Count  
Mean (Full Range)
Unit of measure:  Lesions
Number Analyzed 33 participants 32 participants 65 participants
48.4
(4 to 440)
38.4
(2 to 141)
43.5
(4 to 440)
Total Lesion Count  
Mean (Full Range)
Unit of measure:  Lesions
Number Analyzed 33 participants 32 participants 65 participants
67.3
(13 to 452)
50.1
(5 to 146)
57.8
(5 to 452)
IGA at Baseline   [1] 
Mean (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 33 participants 32 participants 65 participants
3.15
(2 to 4)
3.06
(1 to 4)
3.11
(1 to 4)
[1]
Measure Description: Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)
1.Primary Outcome
Title Lesion Counts (Total, Inflammatory and Non-inflammatory)
Hide Description Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Time Frame Weeks 2, 4, 8 & 12
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 33 32
Mean (Full Range)
Unit of Measure: Lesions
Inflammatory lesions at Week 2 Number Analyzed 30 participants 31 participants
18.4
(1 to 89)
13.4
(0 to 66)
Inflammatory lesions at Week 4 Number Analyzed 24 participants 27 participants
15.8
(0 to 66)
9.9
(1 to 34)
Inflammatory lesions at Week 8 Number Analyzed 24 participants 29 participants
12.1
(0 to 94)
10.2
(0 to 31)
Inflammatory lesions at Week 12 Number Analyzed 22 participants 29 participants
10.5
(0 to 37)
7.0
(0 to 43)
Non-inflammatory lesions at Week 2 Number Analyzed 30 participants 31 participants
30.9
(1 to 152)
33.1
(0 to 131)
Non-inflammatory lesions at Week 4 Number Analyzed 24 participants 27 participants
35.5
(3 to 299)
34.4
(0 to 198)
Non-inflammatory lesions at Week 8 Number Analyzed 24 participants 29 participants
22.1
(0 to 136)
24.3
(0 to 110)
Non-inflammatory lesions at Week 12 Number Analyzed 22 participants 29 participants
19.6
(0 to 78)
20.2
(1 to 60)
Total lesions at Week 2 Number Analyzed 30 participants 31 participants
51.0
(6 to 241)
46.5
(2 to 158)
Total lesions at Week 4 Number Analyzed 24 participants 27 participants
51.4
(0 to 299)
44.3
(2 to 232)
Total lesions at Week 8 Number Analyzed 24 participants 29 participants
34.2
(0 to 136)
34.55
(1 to 134)
Total lesions at Week 12 Number Analyzed 22 participants 29 participants
30.1
(0 to 78)
27.24
(2 to 73)
2.Secondary Outcome
Title Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 33 32
Mean (Full Range)
Unit of Measure: score on a scale
IGA at Week 2 Number Analyzed 30 participants 31 participants
2.77
(1 to 4)
2.9
(1 to 4)
IGA at Week 4 Number Analyzed 24 participants 27 participants
2.83
(1 to 4)
2.59
(1 to 4)
IGA at Week 8 Number Analyzed 24 participants 29 participants
2.21
(1 to 4)
2.48
(1 to 4)
IGA at Week 12 Number Analyzed 22 participants 29 participants
2.23
(1 to 4)
2.31
(1 to 4)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcipotriene Cream Placebo
Hide 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 (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Calcipotriene Cream Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calcipotriene Cream Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/33 (54.55%)      19/32 (59.38%)    
Eye disorders     
Bump on eyelid   0/33 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal disorders     
GI Flu   1/33 (3.03%)  1 0/32 (0.00%)  0
General disorders     
Flu-like symptoms   1/33 (3.03%)  1 2/32 (6.25%)  2
Headache   0/33 (0.00%)  0 2/32 (6.25%)  3
Insomnia   1/33 (3.03%)  1 0/32 (0.00%)  0
Sore Throat   0/33 (0.00%)  0 2/32 (6.25%)  2
Immune system disorders     
Allergic reaction   1/33 (3.03%)  1 1/32 (3.13%)  1
Infections and infestations     
Infection   0/33 (0.00%)  0 2/32 (6.25%)  2
Common cold/allergy   10/33 (30.30%)  11 7/32 (21.88%)  8
Reproductive system and breast disorders     
Menstrual cramps   1/33 (3.03%)  1 1/32 (3.13%)  3
Skin and subcutaneous tissue disorders     
Acne   4/33 (12.12%)  4 2/32 (6.25%)  2
Bruising   1/33 (3.03%)  1 0/32 (0.00%)  0
Bug bite   1/33 (3.03%)  1 0/32 (0.00%)  0
Facial dryness   18/33 (54.55%)  22 5/32 (15.63%)  5
Hives   0/33 (0.00%)  0 1/32 (3.13%)  1
Facial irritation   5/33 (15.15%)  5 2/32 (6.25%)  2
Itching   1/33 (3.03%)  1 2/32 (6.25%)  2
Rash   1/33 (3.03%)  1 2/32 (6.25%)  2
Redness   7/33 (21.21%)  7 2/32 (6.25%)  2
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jenny Kim
Organization: UCLA
Phone: 310-825-5420
EMail: jekim@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Jenny Kim, MD, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01694433    
Other Study ID Numbers: 1R01AR053542-01A2 ( U.S. NIH Grant/Contract )
1R01AR053542-01A2 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2012
First Posted: September 27, 2012
Results First Submitted: March 15, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019