Ketoconazole Foam 2% for the Treatment of Versicolor

Condition(s) targeted: Tinea Versicolor

Intervention: Ketoconazole 2% Foam (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Boni E Elewski, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham

Overall contact:
Wendy C Cantrell, CRNP, Phone: 205-502-9960, Email: wcantrell@uabmc.edu

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/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.

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor

Secondary outcome: To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.

Detailed description: Study Population Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor.

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Wendy C Cantrell, CRNP, Phone: 205-502-9960, Email: wcantrell@uabmc.edu

UAB Dermatology, Birmingham, Alabama 35233, United States; Recruiting
Wendy C Cantrell, CRNP, Phone: 205-502-9960, Email: wcantrell@uabmc.edu
Nell P Sims, Phone: 205-502-9661, Email: wprowell@uabmc.edu

Starting date: November 2008
Ending date: December 2009
Last updated: January 26, 2009