CTRI/2011/091/000062已完成4 期
A Prospective, Randomized, Parallel, Double Blind, Comparative, Multicentric Study to assess the Efficacy, Safety and Tolerability of a Fixed Dose Combination of Mometasone Furoate 0.1% + Fusidic Acid 2% Cream vs. Fixed Dose Combination of Betamethasone Valerate 0.1% + Neomycin Sulphate 0.5% Cream in Patients suffering from Dermatoses with Secondary Bacterial Infection - Momate-F Study
Glenmark Pharmaceuticals Ltd Glenmark House B D Sawant Marg Chakala Andheri East Mumbai0 个研究点目标入组 192 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patient with age 12 yrs and above of both gender
- •Clinical diagnosis of patients with Infected
- •Dermatoses with lesion size of at least 2x2 cms
- •Written informed consent by patient/patient?s guardian
- •Patient willing to follow up
- •Patients with Neutrophils and Gram Positive Cocci on
- •Primary Smear Examination
- •Patients with a minimum score of 1 on the Total
- •Severity Score
排除标准
- •Pregnant or lactating females or wishes to become
- •pregnant during study period
- •Patient known to have hypersensitivity to either
- •Mometasone, Fusidic acid, Neomycin and/ Betamethasone Valerate or oral antibiotics or drugs of similar class
- •Patient not willing to participate in the trial or not in position to give the informed consent
- •Patients who have already received local or systemic
- •antibiotic or any topical therapy in the last 72 hour prior to inclusion
- •Patients having severe infection requiring systemic
- •antibiotic, in the opinion of the treating dermatolo¬gist
- •Patients with Diabetes mellitus or on Antidiabetic
- •Participation in any other clinical trial involving investigational products within 30 days of screening
- •Patients with Clinical diagnosis of Viral or Fungal Skin
- •Patients with skin lesions such as scarring or
- •hyperpigmentation which may confound the assessment
- •Patients with predominant Gram negative flora or
- •polymicrobial flora comprising both Gram Positive
- •Cocci and Gram Negative organisms on smear examination
- •Patients who had received Systemic Immunosuppressives or Oral Steroids within the previous 2 weeks
研究者
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