A PROSPECTIVE, RANDOMIZED STUDY ON EFFICACY, SAFETY, AND TOLERABILITY OF 30% SALICYLIC ACID PEEL WITH ORAL ITRACONAZOLE VS ORAL ITRACONAZOLE IN THE MANAGEMENT OF TINEA CORPORIS INFECTION
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To assess the clinical efficacy of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in management of tinea corporis infection
研究概览
简要总结
Tinea corporis is a common skin condition clinically presents as erythematous or hyperpigmented plaques/patches with regular borders and sometimes with overlying scaling.Management of tinea corporis includes medical treatment like systemic and topical use of antifungals.Rising cases and recurrence with poor treatment response to antifungals highlight the need for new therapeutic strategies.This is a prospective, comparative, randomized clinical study to assess the efficacy, safety, and tolerability of 30% salicylic acid peel with oral itraconazole vs oral itraconazole in the treatment of tinea corporis infection.Each group will have 48 patients each.The study will be conducted at a tertiary hospital.One group will be treated with 30% salicylic acid peel applied locally once a week along with oral itraconazole 100 mg tablet given two times a day for 4 weeks.The other group will be treated with with oral itraconazole tablet 100 mg given two times a day for duration of 4 weeks.The patients will be observed for 2 months period to assess progress, recurrence or any long-term side effects of treatment given.Thus the study aims to find the best possible results in the management of tinea corporis infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are clinically and mycologically positive KOH mount diagnosed case of Tinea corporis.
- •Both sexes men and women Age above 18 years to 60 years Patients with less than 20 percent of body surface area involvement.
- •Patient who will give consent.
排除标准
- •Patients with negative KOH mount and patients who will not give consent.
- •Patients having patches in more than 20 percent BSA Age less than 18 years, Age more than 60 years,pregnancy and lactation Patients with erosions,open wound,secondary infection,maceration at patch area Patients with intertriginous involvement Patients with anemia,liver diseases,kidney diseases, GI diseases Patients with malignancy and lymphoproliferative disorders Patients on potent immunosuppresants,biological DMARDS,organ transplant history Patients with derranged liver and kidney profile Patients using topical or oral antifungals within the preceding 2 weeks Patients known allergic to salicylic acid.
结局指标
主要结局
To assess the clinical efficacy of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in management of tinea corporis infection
时间窗: To assess the clinical efficacy of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in management of tinea corporis infection
次要结局
- To study the safety and tolerability of 30% salicylic acid peel with oral Itraconazole vs oral Itraconazole in the management of tinea corporis infection(3 months)
研究者
Dr Visheshkumar Pralhadrao Mohature
Shri Bhausaheb Hire Government Medical College