Clinical trial NCT00830388: Ketoconazole Foam 2% for the Treatment of Versicolor
Official title: Ketoconazole Foam 2% for the Treatment of Versicolor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinea Versicolor
Keywords: tinea versicolor
ketoconazole
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor
timeFrame: 4 weeks
Secondary outcomes:
measure: To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Dermatology
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Boni E Elewski, MD
role: PRINCIPAL_INVESTIGATOR
References: