Trial Outcomes & Findings for Ketoconazole Foam 2% for the Treatment of Versicolor (NCT NCT00830388)
NCT ID: NCT00830388
Last Updated: 2012-08-22
Results Overview
Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
4 weeks
Results posted on
2012-08-22
Participant Flow
Participant milestones
| Measure |
Ketoconazole 2% Foam
Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketoconazole Foam 2% for the Treatment of Versicolor
Baseline characteristics by cohort
| Measure |
Ketoconazole 2% Foam
n=11 Participants
Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksEleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.
Outcome measures
| Measure |
Ketoconazole 2% Foam
n=11 Participants
Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
|
|---|---|
|
The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor
Negative skin sample
|
7 participants
|
|
The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor
Positive skin sample
|
4 participants
|
SECONDARY outcome
Timeframe: 4 weeksAdverse events were used to assess safety.
Outcome measures
| Measure |
Ketoconazole 2% Foam
n=11 Participants
Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
|
|---|---|
|
To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.
|
0 events
|
Adverse Events
Ketoconazole 2% Foam
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