CTRI/2010/091/000482未知3 期
ASSESSMENT OF EFFICACY, SAFETY AND TOLERABILITY OF FIXED DOSE COMBINATION OF HALOBETASOL 0.05% PLUS FUSIDIC ACID 2% CREAM IN PATIENTS WITH INFECTED DERMATOSES
Glenmark Pharmaceuticals Ltd.4 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
- 4
- 主要终点
- CHANGES IN MEAN SCORE OF CLINICAL SIGNS AND SYMPTOMS AFTER THE TREATMENT
研究概览
简要总结
The present study was undertaken to assess the efficacy, safety and tolerability of Fixed Dose Combination of Halobetasol 0.05%+Fusidic acid 2%cream in infected dermatoses. In this prospective, multicentric open-label study patients were asked to apply Halobetasol 0.05% plus Fusidic acid 2% cream twice daily. 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 yearsClinical 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 halobetasol or Clobetasol or salicylic acid or ointment base.Immunocompromised 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
CHANGES IN MEAN SCORE OF CLINICAL SIGNS AND SYMPTOMS AFTER THE TREATMENT
时间窗: Baseline, 4-6 days and 8-10 days
次要结局
- GLOBAL ASSESSMENT OF EFFICACY OF TREATMENT BY PHYSICIANS AND PATIENTS RESPECTIVELY(Day 8-10)
研究者
研究点 (4)
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