A Prospective, Interventional, Randomized, Parallel, Double blind, active-controlled, Clinical Study to evaluate the Efficacy & Safety of SilverNovaTM Skin Cream as an adjuvant to topical and oral antifungals in the treatment of fungal skin infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1.Reduction of Clinical Signs and Symptoms of skin infection assessed by clinical examination from baseline to end of treatment
研究概览
简要总结
Title of study: “A Prospective, Interventional, Randomized, Parallel, Double blind, active-controlled, Clinical Study to evaluate the Efficacy & Safety of SilverNovaTM Skin Cream as an adjuvant to topical and oral antifungals in the treatment of fungal skin infections’’
**Study Duration:**Study duration of 21 Days , with 14 days treatment and followup on 21 day.
Number of subjects: 80 Subjects
Objectives of the study:
**Primary Objective:**To evaluate the efficacyof SilverNovaTM SkinCream as an adjuvant to topical and oral antifungals in thetreatment of fungal skin infections
Secondary Objetive: To evaluate the safetyof SilverNovaTM Skin Cream as an adjuvant to topical and oral antifungals in the treatment of fungal skininfections.
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 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects age 18 or older, 2.Subjects having any one skin infection mentioned below caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum: -Tinea corporis -Tinea cruris, -Tinea manus, -Tinea pedis infections, -Intertrigo 3.The sum of clinical signs and symptoms scores of the target lesion ≥
- •For scoring scale: a.
- •Signs: Fissuring/cracking, erythema, maceration and scaling b.
- •Symptoms: pruritus and burning/stinging In addition the target lesion must have a minimum score ≥ 2 for erythema and a minimum score ≥ 2 for either pruritus or scaling.
- •4.Subject who, in the opinion of the investigator, are free of any medical condition(s) that may interfere with study participation or affect study measures.
- •Not pregnant, no systemic disease.
- •Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
- •Patients who agreed to return for follow-up visits.
排除标准
- •Females who are pregnant, lactating or planning to become pregnant during the study period.
- •History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
- •History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
- •History of allergy, hypersensitivity, or intolerance to SilverNovaTM Skin Cream, or any other component of the study product.
结局指标
主要结局
1.Reduction of Clinical Signs and Symptoms of skin infection assessed by clinical examination from baseline to end of treatment
时间窗: 21 days
2 Proportion of patients in each group with a Therapeutic Cure in skin infection from baseline to end of treatment
时间窗: 21 days
次要结局
- 1. Self-Assessment of General Health from baseline to End of treatent(2. IP Tolerance)