A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ketoconazole Shampoo, 2% to Ketoconazole Shampoo, 2% (RS) and Both Active Treatments to a Placebo Control in the Treatment of Tinea Versicolor.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- To demonstrate the therapeutic equivalence and safety of the Investigational Product
研究概览
简要总结
To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor.
详细描述
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A, Inc.) to Ketoconazole Shampoo, 2% (Reference Standard) and both active treatments to a placebo control in the treatment of tinea versicolor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non-pregnant female aged ≥ 18 years
- •Subjects must have provided IRB approved written informed consent.
- •Subjects must have clinical diagnosis of tinea versicolor.
- •Subjects must be willing to refrain from using all other tinea versicolor medications or antifungals during the study, other than the investigational product.
- •Female Subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects with a history of hypersensitivity or allergy to ketoconazole, other imidazole antifungals, and/or any of the study medication ingredients.
- •Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of tinea versicolor (e.g., vitiligo, pityriasis alba, post inflammatory hypopigmentation and hyperpigmentation, seborrheic dermatitis, pityriasis rosea, guttate psoriasis, tinea corporis, nummular eczema, secondary syphilis, confluent reticulated papillomatosis of Gougerot and Carteaud, and mycosis fungoides).
- •Treatment for tinea versicolor within the past 6 months that had been unresponsive to prescription topical or oral antifungals.
研究组 & 干预措施
Ketoconazole Shampoo, 2%
The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
干预措施: Ketoconazole Shampoo, 2% (Drug)
Ketoconazole Shampoo, 2% (Reference Standard)
The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
干预措施: Ketoconazole Shampoo, 2% (Reference Standard) (Drug)
Placebo Control
The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate the therapeutic equivalence and safety of the Investigational Product
时间窗: Day 28 Visit
Proportion of subjects with treatment success/cure
次要结局
未报告次要终点