Clinical Trial: Ketoconazole Foam 2% for the Treatment of Versicolor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ketoconazole Foam 2% for the Treatment of Versicolor

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 effectiveness, safety and satisfaction when used to treat tinea versicolor.

Detailed Summary:

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 occurrence of adverse events.
  3. To assess treatment satisfaction as rated by patients

Study Design:

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.


Sponsor: Boni Elewski, MD

Current Primary Outcome: The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor [ Time Frame: 4 weeks ]

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.


Original Primary Outcome: To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor [ Time Frame: 4 weeks ]

Current Secondary Outcome: 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 ]

Adverse events were used to assess safety.


Original Secondary Outcome: 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 ]

Information By: University of Alabama at Birmingham

Dates:
Date Received: January 23, 2009
Date Started: November 2008
Date Completion:
Last Updated: August 21, 2012
Last Verified: July 2012