Repurposing Econazole for the treatment of recalcitrant dermatophytosis, a proof-of-concept study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Proportion of patients showing complete cure (clinical + mycological) at the end of 8 weeks of therapy.
研究概览
简要总结
India is currently facing a surge in recalcitrant dermatophytosis - chronic, recurrent fungal infections where failure of response to commonly used antifungals like itraconazole and terbinafine is often encountered. This resistance is driven by factors such as misuse of steroid-antifungal creams, environmental changes, and the rise of resistant strains like Trichophyton mentagrophytes. Econazole, an imidazole antifungal, has shown broad-spectrum activity and was found to be safe in earlier studies on healthy volunteers. However, its clinical use has been limited to topical forms, which suffer from poor skin penetration and short retention. This will be an open-label, investigator-initiated, academic proof-of-concept study designed to evaluate the safety and effectiveness of oral econazole in patients who have failed to respond to at least two previous courses of standard antifungal treatment. The study will assess complete cure rates (clinical and mycological) at 8 weeks, treatment-emergent adverse events, relapse at 12 weeks, and correlation of plasma and sebum drug levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients of either sex diagnosed with recalcitrant dermatophytosis.
- •Patients diagnosed with recalcitrant dermatophytosis who have demonstrated resistance to two rounds of standard antifungal treatments administered according to the established standard of care, which currently is as follows, Itraconazole 200-400mg/day in Divided doses for 6-8 weeks.
- •If a woman is of child-bearing age, then proper method of birth control should be followed.
- •Both male and female patients must be advised to use birth control methods during the treatment with bedaquiline.
- •Patients Should be willing to give written informed consent.
- •Patients who are willing to comply with the follow-ups and investigations related to the study.
排除标准
- •Known hypersensitivity / contraindications to azole group of drugs.
- •Currently on any other antifungal medications (systemic/topical).
- •On corticosteroid therapy in the past two weeks.
- •Requiring prolonged therapy with proton pump inhibitors.
- •Pulmonary/extrapulmonary tuberculosis on treatment with anti-tubercular drug regimen involving rifampicin.
- •Concomitant therapy with carbamazepine, phenobarbitone, phenytoin.
- •On HMG-CoA Reductase Inhibitors like simvastatin, lovastatin.
- •On systemic immunosuppressive drugs and immunocompromised patients such as HIV positive/ post-renal transplant.
- •Known heart failure or on any drugs for cardiac arrhythmias
- •Pregnant and lactating females.
- •History of lactose intolerance.
结局指标
主要结局
1. Proportion of patients showing complete cure (clinical + mycological) at the end of 8 weeks of therapy.
时间窗: 8 Weeks and 12 weeks
2. Proportion of patients remaining relapse free after 8 weeks of therapy.
时间窗: 8 Weeks and 12 weeks
次要结局
- 1. Incidence of treatment emergent adverse events.(2. Proportions of patients showing clinical cure or mycological cure at the end of 8 weeks of therapy)
研究者
Prof Nusrat Shafiq
Postgraduate institute of medical education and research (PGIMER), Chandigarh