Evaluation of Topical Tretinoin 0.05% Alone Versus Combination With Oral Isotretinoin (0.5 mg/kg/Day) in the Treatment of Plane Warts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Response Rate, as Measured by the Reduction in Number of Lesions at Week 4
研究概览
简要总结
The aim of this study was to compare the effectiveness and safety of topical tretinoin cream 0.05% alone against combination with oral isotretinoin (0.5 mg/kg/day) for treatment of plane warts.
详细描述
This study included 39 patients divided into two groups. Treatment was given for three months duration. Patients were followed-up for further three months to assess the recurrence rate. Combination treatment led to a faster resolution and a higher percentage of complete response. It presents a promising effective alternative option for treatment of plane warts.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 12 years diagnosed with plane warts.
- •Patients who had not received any treatment for warts in the last month.
排除标准
- •Pregnancy and lactation.
- •Abnormal lipid profile.
- •Significant hepatic or renal dysfunction.
- •Depression.
研究组 & 干预措施
Group A
Patients apply tretinoin cream 0.05% once daily at night for 3 months
干预措施: Topical tretinoin 0.05% (Drug)
Group B
Patients apply tretinoin cream 0.05% and receive oral isotretinoin capsule in the dose of 0.5 mg/kg/day for 3 months
干预措施: Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day) (Drug)
结局指标
主要结局
Response Rate, as Measured by the Reduction in Number of Lesions at Week 4
时间窗: Week 4
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion \<50% or no clearance).
Response Rate, as Measured by the Reduction in Number of Lesions at Week 8
时间窗: Week 8
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion \<50% or no clearance).
Response Rate, as Measured by the Reduction in Number of Lesions at Week 12
时间窗: Week 12
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion \<50% or no clearance).
次要结局
- Safety, as Measured by the Number of Patients With at Least one Adverse Effect(week 12)
- Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy(12 weeks after termination of therapy)