A single centre, double blind, placebo controlled, randomized, confirmatory efficacy study of biovite®s calmagenTM dermaceutical cream & lotion for the topical treatment of tinea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mycological cure assessed by negative KOH preparation, fungal culture, and reduction in live spore counts at the end of study
研究概览
简要总结
This is a randomized, double blind, placebo controlled, parallel-group, single center, study designed to confirm the efficacy of Biovite®’s CalmagenTM Dermaceutical cream & lotion for topical application to the affected areas of skin in patients of either sex with severe to very severe presentations of Tinea. The study is divided in three main phases: (a) 1 to 15- days Screening Phase and Randomization (b) Variable Treatment Phase (2 to 12 weeks) (c) Observation phase (12 weeks) The study population will consist of ambulatory human adult male and female patients with clinically proven severe presentations of Tinea who will be randomized to receive either: Treatment A: Biovite®‟s CalmagenTM Dermaceutical cream or lotion for topical application to the affected areas of skin or nails. Treatment B: Placebo cream or lotion for topical application to the affected areas of skin or nails.
The constituents of Biovites Calmagen dermaceutical cream are: very early form of plant life (“Bioactiveâ€) named AMYCOT
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •To be eligible for entry in this study, patient must: 1.Be a male or female ≥ 18 years of age 2.Be diagnosed by the Principal Investigator or designee as suffering from Tinea of combined severity (itching, erythema and scaling) score of 8 or more as in appendix 3 or severe grade of onychomycosis as in appendix 4 of protocol 3.Subjects with positive KOH and positive fungal culture test along with identification of the dermatophyte and presence of live spores.
- •4.Understand and conform to the procedures involved in and agree to participate in the study by giving informed, written consent.
- •5.Be able to give consent for taking photographs of the affected region before, during and after the study period.
排除标准
- •To be eligible for entry in this study, patient must not: 1.Have used any oral or topical Tinea treatments, within one week prior to the screening assessment.
- •2.Have ingested any drug in the week prior to the start of treatment or during the treatment period, which, in the opinion of the Principal Investigator, could compromise the study (Note: Oral, injectable or implant contraceptive for female volunteers is acceptable).
- •3.Have history of allergy or intolerance to any drug, which in the opinion of the principal investigator poses a risk to the patient 4.Be pregnant or breast-feeding females.
- •5.Have received an investigational drug or participated in a clinical trial within the last 30 days 6.Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Principal Investigator, may be jeopardized by participation in this study or by the complications of this therapy 7.Hypersensitivity to Biovite® dermaceutical formulation (cream & lotion) 8.Patient with a positive test for hepatitis B, C, and who is positive or reactive for antibodies to HIV 1 and 2.
结局指标
主要结局
Mycological cure assessed by negative KOH preparation, fungal culture, and reduction in live spore counts at the end of study
时间窗: End of study (4 weeks for Tinea & 12 weeks for Onychomycosis
次要结局
- Improvement in lesions assessed by photographic record at baseline and at end of study(End of study (4 weeks for Tinea and 12 weeks for Onychomycosis))
- Reduction in the extent and the severity of onychomycosis since baseline and at the end of the study.(End of study (12 weeks for Onychomycosis))
- Reduction in the size and the severity of tinea lesions since baseline and at the end of study(End of study (4 weeks for Tinea))