Ketoconazole Foam 2% for the Treatment of Versicolor

Phase 4

Completed

Conditions: Tinea Versicolor

Interventions: Drug: Ketoconazole 2% Foam

Registration Number: NCT00830388

Lead Sponsor: Boni Elewski, MD

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 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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketoconazole 2% Foam	Ketoconazole 2% Foam	Open-label study

Primary Outcome Measures

Name	Time	Method
The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor	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.

Secondary Outcome Measures

Name	Time	Method
To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.	4 weeks	Adverse events were used to assess safety.