Trial Outcomes & Findings for Photocil (Topical) for the Treatment of Vitiligo (NCT NCT01992185)
NCT ID: NCT01992185
Last Updated: 2016-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
90 days
Results posted on
2016-03-10
Participant Flow
Participant milestones
| Measure |
Photocil for Vitiligo
Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo
|
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photocil (Topical) for the Treatment of Vitiligo
Baseline characteristics by cohort
| Measure |
Photocil for Vitiligo
n=7 Participants
Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo
|
Placebo - Sunscreen (SPF 2)
n=8 Participants
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
35.1 years
STANDARD_DEVIATION 15.2 • n=107 Participants
|
36.5 years
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Photocil for Vitiligo
n=7 Participants
Active Drug - Photocil for Vitiligo
Photocil for Vitiligo: Photocil for Vitiligo
|
Placebo - Sunscreen (SPF 2)
n=8 Participants
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)
|
|---|---|---|
|
Percent Repigmentation
|
48.5 Percent Repigmentation
Standard Deviation 16.8
|
2.5 Percent Repigmentation
Standard Deviation 7.1
|
Adverse Events
Photocil for Vitiligo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo - Sunscreen (SPF 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60