ASSESSMENT OF EFFICACY, SAFETY ANDTOLERABILITY OF FIXED DOSE COMBINATION OF MOMETASONE 0.1% + FUSIDIC ACID 2% IN TREATMENT OF PATIENTS WITH CORTICOSTEROID-RESPONSIVE DERMATOSES WITH SECONDARY BACTERIAL INFECTIONS

Glenmark Pharmaceuticals Ltd.2 个研究点分布在 1 个国家目标入组 100 人开始时间: 待定

试验速览

阶段: 3 期
发起方
入组人数: 100
试验地点: 2
主要终点: Clinical signs and symptoms, Severity of lesions, discharge from lesions.

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

In this prospective, multicentric open-label study 115 patients with secondary bacterial infections associated with corticosteroid-responsive dermatoses were asked to apply a fixed dose combination of Mometasone0.1% + Fusidic acid 2% cream. Efficacy parameters included assessment of clinical signs and symptoms, severity and discharge from lesions and bacteriological findings. Overall global assessment of efficacy was undertaken by physicians and patients. Safety and tolerability was also assessed.

研究设计

分配方式: Computer generated randomization
盲法: Open Label

入排标准

入选标准

•Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 12 to 65 years.Clinical diagnosis of patients with infected dermatosesWritten informed consent by patient.Patient willing to follow up.

排除标准

•Pregnant and lactating women.Serious skin disorders, dyspigmentation and extensive scarring in the affected areas.Hypersensitivity to Mometasone or Fusidic acid or cream base.Immuno-compromised states and patients with systemic infections.Patients who have participated in a new drug study in the past 6 months.Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, asthma, collagen disorders, etc.
•or any other serious medical illness.Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.

结局指标

主要结局

Clinical signs and symptoms, Severity of lesions, discharge from lesions.

时间窗: Baseline, Days 6-7 and Days 13-14

次要结局

Global assessment of efficacy of treatment by Physicians and patients(End of the study)

研究者

发起方

Glenmark Pharmaceuticals Ltd.

研究点 (2)

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