Ketoconazole Foam 2% for the Treatment of Versicolor

Objectives

• 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

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.

Inclusion criteria

• 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 criteria

• 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