Phase 4
N=11
Ketoconazole Foam 2% for the Treatment of Versicolor
Tinea Versicolor
Bottom Line
View on ClinicalTrials.gov: NCT00830388 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor — 7; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketoconazole 2% Foam (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Boni Elewski, MD
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor |
7; 4 | — |
| SECONDARY To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00830388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.