NCT01119742终止1 期
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream 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
- 终止
- 入组人数
- 428
- 主要终点
- Therapeutic Cure
研究概览
简要总结
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
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, Investigator, Outcomes Assessor)
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 and the requirements of the India regulatory authorities.
- •If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
- •A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. 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 either pruritus or desquamation/scaling
- •A confirmed clinical diagnosis of interdigital tinea pedis.
- •The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination (potassium hydroxide mount preparation).
- •Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum.
排除标准
- •Use of any of the following within the indicated timeline:
- •Oral or injectable steroids within four weeks of the study start.
- •Any oral anti-fungals within 4 weeks of the study start.
- •Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
- •Any prescription or OTC topical antifungal on the feet within two weeks prior to study entry.
- •Use of any antihistamines within 72 hours of the study start.
- •Any known hypersensitivity to butenafine or other antifungal agents.
- •Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigators evaluation of tinea pedis.
- •Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
研究组 & 干预措施
Vehicle A
Placebo Comparator
4
干预措施: Vehicle A (Drug)
Vehicle B
Placebo Comparator
5
干预措施: Vehicle B (Drug)
Butenafine Hydrochloride 1% A
Experimental
1
干预措施: Butenafine Hydrochloride 1% (Drug)
Butenafine Hydrochloride 1% B
Experimental
2
干预措施: Butenafine Hydrochloride 1% B (Drug)
Butenafine Hydrochloride 1%
Active Comparator
3
干预措施: Butenafine Hydrochloride 1% (Drug)
结局指标
主要结局
Therapeutic Cure
时间窗: 42 Days
Patients with clinical cure and mycologic cure are considered therapeutic cures.
次要结局
- Clinical Cure(42 days)
- Mycologic Cure(42 Days)
研究者
相似试验
已完成
1 期
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea PedisTinea PedisNCT00835510Taro Pharmaceuticals USA548
已完成
3 期
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea PedisTinea PedisNCT01433107Novartis290
进行中（未招募）
3 期
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain ControlBreast CancerNCT03351348Memorial Sloan Kettering Cancer Center165
已完成
3 期
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of KneeChronic PainOsteoarthritis of the KneeNCT00531427Purdue Pharma LP567
已完成
2 期
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and AdolescentsTourette SyndromeNCT03452943Teva Branded Pharmaceutical Products R&D, Inc.119