Status:
COMPLETED
Ketoconazole Foam 2% for the Treatment of Versicolor
Lead Sponsor:
Boni Elewski, MD
Conditions:
Tinea Versicolor
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its ...
Detailed Description
Objectives 1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor 2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the o...
Eligibility Criteria
Inclusion
- Male or female patients, aged 19 years and over.
- Clinical presentation of tinea versicolor.
- Positive KOH using calcofluor.
- The ability to provide informed consent (including photography release)
Exclusion
- Use of topical antifungal to the affected area in the past 30 days
- Use of topical steroid to the affected area in the past 14 days
- If female, positive urine pregnancy test at screening (female patients of childbearing potential must be practicing a reliable method of birth control, not be planning a pregnancy, not be breast-feeding during the study)
- Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results
- Current diagnosis of immunocompromising conditions
- Any medical or psychiatric condition that may interfere with treatment or compliance
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00830388
Start Date
November 1 2008
End Date
September 1 2010
Last Update
August 22 2012
Active Locations (1)
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1
UAB Dermatology
Birmingham, Alabama, United States, 35233