An Open Label, Single arm, Observational Study to Evaluate the Efficacy, Safety & Tolerability of Ketoconazole 2 % in Combination With Beclomethasone 0.025% in Patients With Tinea and sebaceous dermatitisInfections

Med Manor Organics Pvt ltd1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2018年2月19日最近更新: 2019年2月23日

试验速览

阶段: Unknown
状态: 已完成
发起方
入组人数: 50
试验地点: 1
主要终点: To evaluate the efficacyof ketoconazole 2 % in combination with Beclomethasone 0.025% ointment in preventing the Tinea Infections

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is an Open Label, Single arm, Observational Study to Evaluate the Efficacy, Safety & Tolerability of Ketoconazole 2 % in Combination With Beclomethasone 0.025% in (Keto B ointment) Patients With Tinea Infections for evaluation of the safety, efficacy and tolerability of 4Ketoconazole 2 % in combination with Beclomethasone 0.025% in patients with Dermatophytoses (Fungal Infection)

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 12.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•1.Subjects with tinea infections who are either treatment naive or were not on any treatment for at-least 3 months 2.Have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy 3.Subjects aged 12 to 75 years with Tinea Infections 4.Subjects with Epidermal type of Tinea infections 5.Subjects willing to return for all clinic visits and complete all study-related procedures.

排除标准

•1.Subjects with dermal or any other type of fungal infections other than epidermal type 2.Subjects who are either pregnant or breast feeding 3.Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication 4.Subjects taking any other form of alternative treatment like ayurvedic etc..
•for fungal infections 5.Subjects known to have hypersensitivity to any of the ingredients of the formulation.

结局指标

主要结局

To evaluate the efficacyof ketoconazole 2 % in combination with Beclomethasone 0.025% ointment in preventing the Tinea Infections

时间窗: 2 Weeks form base line

次要结局

To evaluate the safety and tolerability of ketoconazole 2 % in combinaton with Beclomethasone 0.025% cream based on the adverse effects as mentioned by the patient(total 4 week)

研究者

发起方

Med Manor Organics Pvt ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (1)

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