Ketoconazole Foam 2% for the Treatment of Versicolor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor
研究概览
简要总结
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.
详细描述
Objectives
- To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
- To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Ketoconazole 2% Foam
Open-label study
干预措施: Ketoconazole 2% Foam (Drug)
结局指标
主要结局
The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor
时间窗: 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.
次要结局
- To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.(4 weeks)
研究者
Boni Elewski, MD
Principal Investigator
University of Alabama at Birmingham