A prospective, randomized, two-arm, double-blind, active-controlled, parallel, multicentre, non-inferiority, phase III clinical trial to assess the efficacy and safety of Naftifine hydrochloride cream 2% w/w as compared to Terbinafine hydrochloride cream 1% w/w in patients with superficial fungal infection of the skin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 6
- 主要终点
- Clinical cure at the end of the treatment
研究概览
简要总结
A prospective, randomized, two-arm, double-blind, active-controlled, parallel, multicentre, non-inferiority, phase III clinical trial.
Study Groups Test drug: Naftifine hydrochloride cream 2% w/w & Reference drug: Terbinafine hydrochloride cream 1% w/w w .Total of 268 patients with dermatophytosis at geographically distributed centres in India will be enrolled in this clinical trial to evaluate the efficacy and safety of naftifine hydrochloride cream 2% w/w as compared to terbinafine hydrochloride cream 1% w/w. The enrolled patients would be assigned to either of the 2 study groups in a double-blinded manner according to the centralized computer generated randomization in a 1:1 (test: reference) ratio.
In this study, the patients with dermatophytosis will be screened (visit 1) upto one day prior to their enrollment. The eligible patients will then be enrolled and randomized to either of the 2 study groups in a double-blinded manner during the baseline visit (visit 2, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 1 (visit 3), week 2 (visit 4) and week 4 / 2 weeks after visit 4 (visit 5). This will be a parallel group study and all the enrolled patients will be instructed to apply the study medication topically regularly for a treatment period of 2 weeks.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender of 18 to 65 years of age (both inclusive)
- •Patients with acute symptomatic tinea corporis or tinea cruris limited to single body region and with limited involvement i.e., < 5 skin lesions with each having greatest diameter of < 5 cm
- •Mycological diagnosis of tinea corporis or tinea cruris confirmed by detection of fungal hyphae on a microscopic KOH test
- •Patients with total clinical score of at least 5
- •Patients willing to provide written informed consent and comply with the protocol requirements.
排除标准
- •Patients with history of hypersensitivity to naftifine or terbinafine
- •Patients with extensive or disseminated tinea infections
- •Patients with tinea infection other than tinea corporis or tinea cruris such as tinea infection of face, scalp or feet
- •Patients with diagnosis of tinea infection requiring systemic treatment according to the severity of lesion as judged by the investigator
- •Patients having skin lesions with secondary bacterial infection
- •Patients with other dermatological conditions which may confound the disease assessment and treatment evaluation e.g., contact dermatitis, atopic dermatitis, psoriasis, urticaria
- •Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine or hematological disorders or malignancy
- •Patients with immunosuppressive disorder e.g., HIV infection or patients on immunosuppressive medications e.g., systemic corticosteroids or cytotoxic drugs
- •Patients with hepatic dysfunction (serum transaminases >_ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine >_ 2.5 mg/dl)
- •Patients who have used the following medications: a.
- •Topical antifungal agent within 30 days prior to enrollment b.
- •Systemic antifungal agent within 8 weeks (8 months for oral terbinafine) prior to enrollment c.
- •Topical corticosteroid on the affected area(s) within 30 days prior to enrollment d.
- •Systemic antihistamine agent within 3 days prior to enrollment f.
- •Any other topical treatment on the affected area(s) within 7 days prior to enrollment
- •Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •Patients with history of alcohol and/or drug abuse
- •Participation in another clinical trial in the past 3 months prior to screening
- •Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Clinical cure at the end of the treatment
时间窗: 2 weeks
次要结局
- Efficacy:(1.Mycological cure at the end of the treatment)