Comparative Efficacy of Topical Salicylic Acid/Lactic Acid, Intralesional Candida Antigen, and Their Combination in the Treatment of Warts: A Randomized, Assessor-Blinded, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
Objective: To compare the efficacy, safety, and recurrence rates of topical salicylic acid/lactic acid (SA/LA) monotherapy (Group A), intralesional Candida antigen (CA) monotherapy (Group B), and their combination (Group C) for the treatment of 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
- Single (Outcomes Assessor)
盲法说明
Assessor-Blinded (Outcome Assessor Only)
入排标准
- 年龄范围
- 5 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single or multiple warts.
- •Aged 5 to 60 years.
- •Eligible for both topical and intralesional treatments.
- •No prior wart treatment for at least 1 month.
排除标准
- •Pregnancy or lactation.
- •Immunosuppression or use of immunosuppressive drugs.
- •Known sensitivity to study ingredients.
- •Systemic/local inflammation or infection.
- •History of bleeding/clotting disorder, or use of anticoagulants/NSAIDs.
- •History of asthma, allergic skin disorders, or convulsions.
- •History of chronic systemic diseases (renal/hepatic failure, cardiovascular disorders).
研究组 & 干预措施
Intralesional Monotherapy
Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.
干预措施: Candida Antigen Intralesional Injection (Biological)
topical monotherapy
Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.
干预措施: Salicylic Acid/Lactic Acid Topical Solution (Drug)
Combination Therapy
Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions, with topical Salicylic Acid 40% and Lactic Acid 16% applied in between.
干预措施: Candida Antigen and Salicylic Acid/Lactic Acid (Combination Product)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: 3 months post-treatment
Percentage of patients achieving complete disappearance of all warts.
次要结局
- Safety and Tolerability Profile(At each visit (every 2 weeks) and 3 months post-treatment)
- Recurrence Rate(6 months post-treatment)
- Distant Wart Clearance Rate(3 months post-treatment)
研究者
Ghada Mohamed Shams
Principal investigator
Benha University