Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 主要终点
- Clinical and mycological cure rate in pityriasis versicolor.
研究概览
简要总结
Pityriasis versicolor is a common superficial fungal infection caused by Malassezia species, characterized by hypo- or hyper-pigmented scaly patches on the skin. Topical antifungal agents are the mainstay of treatment. Ketoconazole has been widely used; however, newer agents such as luliconazole may offer improved efficacy and shorter treatment duration. This randomized controlled study aims to compare the efficacy and safety of topical luliconazole versus topical ketoconazole in patients with pityriasis versicolor. Treatment response will be assessed clinically and mycologically to determine comparative outcomes.
详细描述
Pityriasis versicolor is a superficial fungal infection caused by Malassezia species and is commonly treated with topical antifungal agents. Ketoconazole is a conventional treatment, while luliconazole is a newer topical antifungal with potent activity against fungal organisms. This randomized controlled trial is designed to compare the clinical and mycological efficacy, safety, and tolerability of topical luliconazole versus topical ketoconazole in patients diagnosed with pityriasis versicolor. Eligible participants will be randomly allocated into two treatment groups and followed for treatment response and adverse effects. The findings of this study may help determine a more effective topical treatment option for pityriasis versicolor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study; no participants, care providers, investigators, or outcome assessors are masked.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with pityriasis versicolor.
排除标准
- •Immunocompromised patients
研究组 & 干预措施
Topical Luliconazole 1% cream
Participants will receive topical luliconazole 1% cream applied once daily to affected areas for the treatment of pityriasis versicolor.
干预措施: Luliconazole Cream 1% (Drug)
Topical ketoconazole 2% cream
Participants will receive topical ketoconazole 2% cream applied twice daily to affected areas for the treatment of pityriasis versicolor.
干预措施: Topical ketoconazole 2% cream (Drug)
结局指标
主要结局
Clinical and mycological cure rate in pityriasis versicolor.
时间窗: 4 weeks
Proportion of participants achieving both clinical and mycological cure.
Clinical and mycological cure
时间窗: 4 weeks after completion of treatment
Proportion of participants achieving both clinical and mycological cure
次要结局
未报告次要终点
研究者
Sana Rafique
Post graduate trainee
PAEC General Hospital, Islamabad