A prospective, randomized, double blind, two arm, comparative clinical study to evaluate the safety and efficacy of Nixoderm tin in tinea corporis infection in adult subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- study visits to be evaluated by following parameters:
研究概览
简要总结
Tinea corporis is a superficial fungal skin infection of the body caused by dermatophytes. Tinea corporis is present worldwide. It is defined explicitly by the location of the lesions that may involve the trunk, neck, arms, and legs. Alternative names exist for dermatophyte infections that affect the other areas of the body. These include the scalp (tinea capitis), the face (tinea faciei), hands (tinea manuum), the groin (tinea cruris), and feet (tinea pedis). The dermatophyte’s ability to attach to the keratinized tissue of skin forms the basis for the dermatophytoses (superficial fungal skin infections). The dermatophytes causing tinea corporis belong to genera Trichophyton, Epidermophyton, and Microsporum. Trichophyton rubrum is the most common species to cause dermatophyte infections in the last 70 years. T. Rubrum accounts for 80 to 90% of the strains. Other common isolates include Trichophyton mentagrophytes and Microsporum audouinii. Infection typically occurs with direct contact with the skin from the soil, animals, or the skin of other humans. Tinea corporis is exceedingly common worldwide. Dermatophytes are the most prevalent agents of superficial fungal infections. Excessive heat, high relative humidity, and fitted clothing have correlations to more severe and frequent disease.3 The lifetime risk of acquiring tinea corporis is estimated to be 10–20%. Tinea corporis occurs most frequently in post-pubertal children and young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Male and Female participants 2.Aged between 18-65 years.
- •3.Diagnosed with tenia corporis infection 4.Willing to give Informed Consent.
- •5.Willing to complete the study assessments/questionnaires.
- •6.Willing to avoid usage of his/her own skin care products in controlling tenia corporis infection for at least one week before the commencement and during this study.
排除标准
- •Pregnancy or breast feeding.
- •Participants with the history of hypersensitivity to skin care products.
- •Participants with mild to severe anaphylaxis reaction.
- •Participants with pre existing severe systemic disease necessitating longterm medication.
- •Participants with any other concomitant skin diseases such as psoriasis eczema etc.
- •Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
- •History of cancer, including solid tumors hematologic malignancies and carcinoma in situ.
- •Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
结局指标
主要结局
study visits to be evaluated by following parameters:
时间窗: Screening, Day 15 and Day 30
study visits by Visual Analogue Scores.
时间窗: Screening, Day 15 and Day 30
1. Percentage reduction in ringworm infection from baseline to all
时间窗: Screening, Day 15 and Day 30
Dermatological Assessments
时间窗: Screening, Day 15 and Day 30
Percentage reduction in itching and scaling from baseline to all
时间窗: Screening, Day 15 and Day 30
KOH preparation of fungus
时间窗: Screening, Day 15 and Day 30
次要结局
- The safety of Nixoderm Tin in tenia corporis infection from baseline(to all study visits is determined by evaluating adverse events)
