A Phase 4 interventional study of Ketoconazole 2% Foam in Tinea Versicolor, sponsored by Boni Elewski, MD. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-22.
Sponsored by Boni Elewski, MD · Phase 4, Interventional, and Treatment
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
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.
This is the only study on the registry with Boni Elewski, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open-label study
Drug: Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Also known as: Extina Foam
The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor
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.
Time frame: 4 weeks
To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.
Adverse events were used to assess safety.
Time frame: 4 weeks
| Milestone | Ketoconazole 2% Foam |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| participants | Ketoconazole 2% Foam |
|---|---|
| Negative skin sample | 7 |
| Positive skin sample | 4 |
Adverse events were used to assess safety.
| events | Ketoconazole 2% Foam |
|---|---|
| To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketoconazole 2% Foam | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Ketoconazole 2% Foam |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Ketoconazole 2% Foam |
|---|---|
| Female | 8 |
| Male | 3 |
| Region of Enrollment(participants) | Ketoconazole 2% Foam |
|---|---|
| United States | 11 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Tinea Versicolor