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临床试验/CTRI/2021/05/033812
CTRI/2021/05/033812尚未招募不适用

A randomized double blind study comparing topical ketoconazole 2% lotion and topical oxiconazole nitrate 1% lotion in treatment of pityriasis versicolor

Vinayaka Missions Medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Compare the clinical responses by global assessment to ketoconazole lotion and oxiconazole nitrate lotion

研究概览

简要总结

After obtaining informed written consent, 60 patients of pityriasis versicolor will be recruited for the study after applying inclusion criteria(clinically and mycologically diagnosed with pityriasis versicolor, both sexes, age above 18 years) and exclusion criteria(patient who have diabetes, malignancy, HIV, under steroids/ immunosuppressive drugs and other known immunocompromised states, patients with history of adverse response to imidazole derivatives or to any component of the formulation, patient who received any kind of anti fungal treatment in last 3 months, pregnant women, severely ill patients, non – compliant patients).

They will be randomized into two groups of 30 each, one group treated with topical ketoconazole 2% lotion once daily for 4 weeks and other group treated with topical oxiconazole nitrate 1% lotion once daily for 4 weeks.

Patient follow up to be done at end of first week , fourth week and 3 months. During each visit, clinical response is graded as cleared, excellent, good, fair, poor, worse. A close watch on any adverse effects of the drugs to be during each visit and relapse rate of disease at end of 3 weeks monitored and documented.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Clinically and Mycologically diagnosed with Pityriasis versicolor Both sexes Patients belonging to age above 18 years.

排除标准

  • Patient who have diabetes, malignancy, HIV, under steroids/immunosuppressive drugs and other known immunocompromised states Patients with history of adverse response to imidazole derivatives or to any component of the formulation Patient who received any kind of anti fungal treatment in last 3 months Pregnant women Severely ill patients Non – compliant patients.

结局指标

主要结局

Compare the clinical responses by global assessment to ketoconazole lotion and oxiconazole nitrate lotion

时间窗: At end of first week, fourth week and 3 months

次要结局

  • Relapse rate of disease(At end of 3 months)

研究者

申办方类型
Private medical college

研究点 (1)

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