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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketoconazole 2% Foam | Experimental | Open-label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketoconazole 2% Foam | Drug | Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boni E Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Dermatology | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketoconazole 2% Foam | Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketoconazole 2% Foam | Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketoconazole 2% Foam | Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Cantrell | University of Alabama at Birmingham | 205-502-9960 | wcantrell@uabmc.edu |
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| ID | Term |
|---|---|
| D014010 | Tinea Versicolor |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Posted | Number | events | 4 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
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| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |