Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
11 participants
INTERVENTIONAL
2008-11-30
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketoconazole 2% Foam
Open-label study
Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical presentation of tinea versicolor.
3. Positive KOH using calcofluor.
4. The ability to provide informed consent (including photography release)
Exclusion Criteria
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
19 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boni Elewski, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Boni Elewski, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boni E Elewski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB Dermatology
Birmingham, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F080520002
Identifier Type: -
Identifier Source: org_study_id