Ketoconazole Foam 2% for the Treatment of Versicolor
Ketoconazole Foam 2% for the Treatment of Versicolor
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.
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.
Inclusion Criteria:

 1. Male or female patients, aged 19 years and over.

 2. Clinical presentation of tinea versicolor.

 3. Positive KOH using calcofluor.

 4. The ability to provide informed consent (including photography release)

 Exclusion Criteria:

 1. Use of topical antifungal to the affected area in the past 30 days

 2. Use of topical steroid to the affected area in the past 14 days

 3. 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)

 4. Patients with a dermatologic condition in the region of the treatment site that in the
 investigator's opinion may interfere with the study results

 5. Current diagnosis of immunocompromising conditions

 6. Any medical or psychiatric condition that may interfere with treatment or compliance