Comparative assessment of the efficacy, safety and cost effectiveness of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses : A prospective, Randomized , open label, parallel study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To Compare the efficacy of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses by clinical examination with the help of 4 – point Physician Global Assessment (PGA) scale
研究概览
简要总结
Thesis/Dissertation protocol- Superficial mycotic infection such as‘Dermatophytoses’ is an extremely common infection occurring throughout theworld with a reported incidence of 20% in USA.The disease is caused bydermatophytes belonging to genera of Trichophyton, Microsporum and Epidermophyton.The fungal infections of the skin and its appendages are more common intropical countries like India due to environmental factors like heat (summer)and humidity (monsoon).However in India, the most commonly occurringclinical type of dermatophytoses for adults includes, tinea corporis (36-59%)and tinea cruris (12-27%). Imidazoles, allylamines and triazoles are mosteffective agents for dermatophytoses. Topical daily antifungal therapy usuallyinvolves imidazoles (namely, Sertaconazole and Luliconazole) andallylamines (Terbinafine). Thecomparative effectiveness and safety of luliconazole and sertaconazole remainsunclear and well-designed head-to-head trials of newer antifungals are warrantedto establish these agents relative efficacy in treating tinea infections.Sothis study is planned to compare sertaconazole with luliconazole in patientswith dermatophytoses.
complete study plan-
**Day 0-**Written informed consent , baseline investigation (10% KOH) and assessment of scale (PGA-Physician Global Assessment) -Drug given (either sertaconazole 2% cream or luliconazole 1% cream)
**End of treatment-**baseline investigation (10% KOH) and assessment of scale (PGA-Physician Global Assessment) **After 2 weeks of end of treatment-**baseline investigation (10% KOH) , assessment of scale (PGA-Physician Global Assessment),safety and cost effectiveness
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults between the age group of 18 to 70 years of either gender, with clinical diagnosis and mycological confirmation (positive KOH test) for tinea corporis and tinea cruris infections, will be included in the study.
- •Patient having a Physician global assessment (PGA) composite score of at least 5 will be included in the study.
- •Patient willing to give written informed consent will be included in the study.
排除标准
- •Patients having clinical diagnosis of tinea infections other than tinea corporis and tinea cruris, 2)Patients having extensive fungal infection, 3)Patients who had received topical or oral antifungal agents upto four weeks prior to the initiation of the study, 4)History of hypersensitivity to study drugs, 5)Immunocompromised patients, 6)Patients having superadded bacterial infection, 7)Pregnant or lactating women.
结局指标
主要结局
To Compare the efficacy of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses by clinical examination with the help of 4 – point Physician Global Assessment (PGA) scale
时间窗: Time duration- 6 week | follow up at 4th week and 6th week
次要结局
- 1)To assess the safety and relapse in patients with dermatophytoses receiving sertaconazole (2%) cream or luliconazole (1%) cream by clinical examination , KOH mount, and monitoring adverse drug events.(2)To assess the cost effectiveness of sertaconazole (2%) cream and luliconazole (1%) cream in patients with dermatophytoses)