Ketoconazole Foam 2% for the Treatment of Versicolor
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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.
Condition | Intervention | Phase |
---|---|---|
Tinea Versicolor |
Drug: Ketoconazole 2% Foam |
Phase 4 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Ketoconazole Foam 2% for the Treatment of Versicolor |
- The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Adverse events were used to assess safety.
Enrollment: | 11 |
Study Start Date: | November 2008 |
Study Completion Date: | September 2010 |
Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Ketoconazole 2% Foam
Open-label study
|
Drug: Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Other Name: Extina Foam
|
Detailed Description:
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
United States, Alabama | |
UAB Dermatology | |
Birmingham, Alabama, United States, 35233 |
Principal Investigator: | Boni E Elewski, MD | University of Alabama at Birmingham |
No publications provided
Responsible Party: | Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00830388 History of Changes |
Other Study ID Numbers: | F080520002 |
Study First Received: | January 23, 2009 |
Results First Received: | May 1, 2012 |
Last Updated: | August 21, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
tinea versicolor ketoconazole |
Additional relevant MeSH terms:
Tinea Tinea Versicolor Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases Ketoconazole |
14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 18, 2012