Trial Outcomes & Findings for "Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy" (NCT NCT01694433)
NCT ID: NCT01694433
Last Updated: 2019-05-07
Results Overview
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
66 participants
Primary outcome timeframe
Weeks 2, 4, 8 & 12
Results posted on
2019-05-07
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Baseline Visit
|
33
|
32
|
|
Overall Study
COMPLETED
|
22
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"
Baseline characteristics by cohort
| Measure |
Calcipotriene Cream
n=33 Participants
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
|
Placebo
n=32 Participants
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
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Inflammatory Lesion Count
|
16.8 Lesions
n=5 Participants
|
11.7 Lesions
n=7 Participants
|
14.3 Lesions
n=5 Participants
|
|
Non-inflammatory Lesion Count
|
48.4 Lesions
n=5 Participants
|
38.4 Lesions
n=7 Participants
|
43.5 Lesions
n=5 Participants
|
|
Total Lesion Count
|
67.3 Lesions
n=5 Participants
|
50.1 Lesions
n=7 Participants
|
57.8 Lesions
n=5 Participants
|
|
IGA at Baseline
|
3.15 score on a scale
n=5 Participants
|
3.06 score on a scale
n=7 Participants
|
3.11 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 2, 4, 8 & 12Population: The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
Outcome measures
| Measure |
Calcipotriene Cream
n=33 Participants
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
|
Placebo
n=32 Participants
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
|
|---|---|---|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Inflammatory lesions at Week 2
|
18.4 Lesions
Interval 1.0 to 89.0
|
13.4 Lesions
Interval 0.0 to 66.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Inflammatory lesions at Week 4
|
15.8 Lesions
Interval 0.0 to 66.0
|
9.9 Lesions
Interval 1.0 to 34.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Inflammatory lesions at Week 8
|
12.1 Lesions
Interval 0.0 to 94.0
|
10.2 Lesions
Interval 0.0 to 31.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Inflammatory lesions at Week 12
|
10.5 Lesions
Interval 0.0 to 37.0
|
7.0 Lesions
Interval 0.0 to 43.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Non-inflammatory lesions at Week 2
|
30.9 Lesions
Interval 1.0 to 152.0
|
33.1 Lesions
Interval 0.0 to 131.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Non-inflammatory lesions at Week 4
|
35.5 Lesions
Interval 3.0 to 299.0
|
34.4 Lesions
Interval 0.0 to 198.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Non-inflammatory lesions at Week 8
|
22.1 Lesions
Interval 0.0 to 136.0
|
24.3 Lesions
Interval 0.0 to 110.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Non-inflammatory lesions at Week 12
|
19.6 Lesions
Interval 0.0 to 78.0
|
20.2 Lesions
Interval 1.0 to 60.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Total lesions at Week 2
|
51.0 Lesions
Interval 6.0 to 241.0
|
46.5 Lesions
Interval 2.0 to 158.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Total lesions at Week 4
|
51.4 Lesions
Interval 0.0 to 299.0
|
44.3 Lesions
Interval 2.0 to 232.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Total lesions at Week 8
|
34.2 Lesions
Interval 0.0 to 136.0
|
34.55 Lesions
Interval 1.0 to 134.0
|
|
Lesion Counts (Total, Inflammatory and Non-inflammatory)
Total lesions at Week 12
|
30.1 Lesions
Interval 0.0 to 78.0
|
27.24 Lesions
Interval 2.0 to 73.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 & 12Population: The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.
Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)
Outcome measures
| Measure |
Calcipotriene Cream
n=33 Participants
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
|
Placebo
n=32 Participants
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
|
|---|---|---|
|
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
IGA at Week 2
|
2.77 score on a scale
Interval 1.0 to 4.0
|
2.9 score on a scale
Interval 1.0 to 4.0
|
|
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
IGA at Week 4
|
2.83 score on a scale
Interval 1.0 to 4.0
|
2.59 score on a scale
Interval 1.0 to 4.0
|
|
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
IGA at Week 8
|
2.21 score on a scale
Interval 1.0 to 4.0
|
2.48 score on a scale
Interval 1.0 to 4.0
|
|
Acne Severity as Assessed With the Investigator's Global Assessment (IGA)
IGA at Week 12
|
2.23 score on a scale
Interval 1.0 to 4.0
|
2.31 score on a scale
Interval 1.0 to 4.0
|
Adverse Events
Calcipotriene Cream
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcipotriene Cream
n=33 participants at risk
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
|
Placebo
n=32 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
12.1%
4/33 • Number of events 4 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Immune system disorders
Allergic reaction
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/33 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Bruising
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Bug bite
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Eye disorders
Bump on eyelid
|
0.00%
0/33 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Common cold/allergy
|
30.3%
10/33 • Number of events 11 • 12 weeks
|
21.9%
7/32 • Number of events 8 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Facial dryness
|
54.5%
18/33 • Number of events 22 • 12 weeks
|
15.6%
5/32 • Number of events 5 • 12 weeks
|
|
General disorders
Flu-like symptoms
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Reproductive system and breast disorders
Menstrual cramps
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
3.1%
1/32 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
GI Flu
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
General disorders
Headache
|
0.00%
0/33 • 12 weeks
|
6.2%
2/32 • Number of events 3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/33 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
|
General disorders
Insomnia
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Facial irritation
|
15.2%
5/33 • Number of events 5 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33 • Number of events 1 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Redness
|
21.2%
7/33 • Number of events 7 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
General disorders
Sore Throat
|
0.00%
0/33 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place