Ketoconazole Foam 2% for the Treatment of Versicolor
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ketoconazole Foam 2% for the Treatment of Versicolor|
- The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Adverse events were used to assess safety.
|Study Start Date:||November 2008|
|Study Completion Date:||September 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Ketoconazole 2% Foam
Drug: Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Other Name: Extina Foam
- To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
- To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.
- To assess treatment satisfaction as rated by patients
This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830388
|United States, Alabama|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Boni E Elewski, MD||University of Alabama at Birmingham|