CTRI/2022/03/041524已完成不适用
A Multicenter, Randomized, Double-Blind, Three- Arm, Placebo-Controlled, Parallel Design, Study to Evaluate the Efficacy and Safety of Ketoconazole 2% Shampoo of Cadila Healthcare Limited with Ketoconazole Shampoo, 2% of Perrigo New York Inc. in Subjects with Tinea Versicolor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 17
- 主要终点
- To evaluate bioequivalence (with clinical endpoint) of test product (Ketoconazole 2% Shampoo) of Cadila Healthcare Limited with reference product (Ketoconazole Shampoo, 2%) of Perrigo New York Inc. in subjects with tinea versicolor.
研究概览
简要总结
A study is Multicenter, Randomized, Double-Blind, Three- Arm, Placebo-Controlled, Parallel Design Study. This clinical trial intended to Evaluate the Efficacy and Safety of Ketoconazole 2% Shampoo of Cadila Healthcare Limited with Ketoconazole Shampoo, 2% of Perrigo New York Inc. in Subjects with Tinea Versicolor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject will be eligible for inclusion in this study only if all of the following criteria apply: 1 Male or non-pregnant or non-lactating female subjects between 18 years of age or above.
- •2 Subjects with a clinical diagnosis of tinea versicolor and both of the following A combined severity score of at least 4, with at least one of the following signs and symptoms rated at least 2, using the following scale: Signs/symptoms Scale Presence of infection with Malassezia furfur (Pityrosporum orbiculare or P.
- •ovale) confirmed by a positive KOH cellophane tape test showing the characteristic “spaghetti and meatballs†appearance of the round budding yeast cells and short hyphae.
- •Subject able to understand the investigational nature of this study and give written informed consent prior to study entry.
- •Female of childbearing potential, have a negative urine pregnancy test at the baseline visit and willing to use an acceptable form of birth control including abstinence during the study.
- •Able to comply with study requirements in the opinion of Investigator.
排除标准
- •Subject will not be eligible for inclusion in this study if any of the following criteria apply
- •Has recent history or evidence of other fungal infections, including oral, vaginal or chronic mucocutaneous candidiasis, systemic fungal infections or dermatophyte infections that may interfere with of tinea versicolor.
- •Use of any systemic or topical antifungals, corticosteroids or immunosuppressive drugs within 30 days prior to baseline visit.
- •Use of any prescription or over the counter OTC, topical antifungal, anti-pruritus, corticosteroid, selenium sulfide or zinc pyrithione preparations within 14 days prior to baseline visit or used antihistamines that may interfere with the subjects ability to experience cutaneous sensations within 24 hours prior to baseline visit unless on a stable dose of antihistamine for at least 30 days.
- •Any known hypersensitivity or allergy to ketoconazole or other imidazole antifungals or other shampoos, soaps or cosmetics.
- •Treatment for tinea versicolor within the past six months that has been unresponsive to prescription topical or oral antifungals.
- •History of alcohol or other substance abuse within the last one year.
- •Any other clinical investigation using experimental drug within past 30 days of prior to baseline visit.
- •Institutionalized subject.
- •Live in the same household as currently enrolled subject.
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into the trial.
结局指标
主要结局
To evaluate bioequivalence (with clinical endpoint) of test product (Ketoconazole 2% Shampoo) of Cadila Healthcare Limited with reference product (Ketoconazole Shampoo, 2%) of Perrigo New York Inc. in subjects with tinea versicolor.
时间窗: Day 28 (±4 days)
2. To evaluate the superiority of test and reference product with placebo in subjects with tinea versicolor.
时间窗: Day 28 (±4 days)
次要结局
- To assess safety and tolerability of study treatments.(Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).)
研究者
研究点 (17)
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