NCT01580891已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,053
- 主要终点
- Therapeutic Cure
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
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
- Double (Participant, 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
- 否
入选标准
- •Male or non-pregnant, non-lactating females 18 years of age or older.
- •Signed informed consent form, which meets all criteria of current FDA regulations.
- •If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
- •A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
- •A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
- •The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.
排除标准
- •Females who are pregnant, lactating or likely to become pregnant during the study.
- •Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
- •Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
- •Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
- •Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
- •Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
- •Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
- •Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- •Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- •Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.
- •Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.
- •Patients who would be non-compliant with the requirements of the study protocol.
- •Participation in a research study within 30 days prior to baseline visit.
- •Employees or family members of employees of the research center or investigator.
- •Previous participation in this study.
研究组 & 干预措施
Naftifine HCl Cream 1%
Experimental
Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.)
干预措施: Naftifine HCl Cream 1% (Drug)
Naftin® (Naftifine HCl) Cream 1%
Active Comparator
Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals)
干预措施: Naftin® (Naftifine HCl) Cream 1% (Drug)
Placebo topical cream
Placebo Comparator
Placebo topical cream (Taro Pharmaceuticals Inc.)
干预措施: Placebo topical cream (Drug)
结局指标
主要结局
Therapeutic Cure
时间窗: 42 Days
Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures.
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea PedisTinea PedisNCT02132260Taro Pharmaceuticals USA890
终止
3 期
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis ExternaOtitis ExternaNCT01910155Par Pharmaceutical, Inc.455
已完成
1 期
Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.Actinic KeratosisNCT01788007Taro Pharmaceuticals USA443
已完成
3 期
Evaluation of Clinical Equivalence Between Two Lubiprostone ProductsChronic Idiopathic ConstipationNCT01372423Anchen Pharmaceuticals, Inc808
已完成
3 期
Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%Osteo Arthritis of the KneeNCT01456611Anchen Pharmaceuticals, Inc749