Tinea Versicolor
Conditions
Keywords
tinea versicolor, ketoconazole
Brief 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.
Detailed description
Objectives 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.
Interventions
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
Sponsors
Boni Elewski, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female patients, aged 19 years and over. 2. Clinical presentation of tinea versicolor. 3. Positive KOH using calcofluor. 4. The ability to provide informed consent (including photography release)
Exclusion criteria
1. Use of topical antifungal to the affected area in the past 30 days 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. | 4 weeks | Adverse events were used to assess safety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketoconazole 2% Foam Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Ketoconazole 2% Foam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ketoconazole 2% Foam | The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor | Negative skin sample | 7 participants |
| Ketoconazole 2% Foam | The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor | Positive skin sample | 4 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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 events |