Comparative efficacy and safety of itraconazole, SUBA-itraconazole, and voriconazole in the treatment of recalcitrant dermatophytosis – A randomized, open label, active comparator clinical trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- • Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy.
研究概览
简要总结
Background Justification:
Till date, no robust clinical trials are available to establish the superiority of SUBA- itraconazole over itraconazole and voriconazole in terms of better cure rate or lower relapse rate in the management of dermatophytosis.
Research Question
How does SUBA-itraconazole compare with itraconazole and voriconazole in terms of efficacy, safety and pharmacokinetics.
Objectives:
Primary objective:
To evaluate the efficacy of SUBA-itraconazole vs itraconazole vs voriconazole in the treatment of recalcitrant dermatophytosis
Secondary objectives:
1.To evaluate the safety of SUBA-itraconazole vs itraconazole vs voriconazole in the treatment of recalcitrant dermatophytosis.
-
To evaluate the population pharmacokinetic parameters and sebum concentration of SUBA-itraconazole, itraconazole and voriconazole.
-
To evaluate the role of IL-17 and IgE as immunological markers in recalcitrant dermatophytosis
Endpoints:
Primary endpoint:
**1.**Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy
Clinical cure is defined as Score - 0 in Total Symptom Score.
Mycological cure is defined as negative KOH mount at the end of 8 weeks of therapy.
Secondary endpoints;
1. Incidence of treatment emergent adverse events.
-
Proportions of patients showing clinical cure or mycological cure at the end of 8 weeks of therapy
-
Proportion of patients remaining relapse free for 3 months after 8 weeks of therapy (only in case of completely cured patients).
4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8.
- Correlation of Serum IL-17 and IgE levels with respect to Total Symptom Score at the end of therapy.
6. Correlation of population pharmacokinetics with the Total Symptom Score at the end of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients diagnosed with recalcitrant dermatophytosis (persistent disease with duration ranging 6 months to 1 year / encountered reoccurrence of the disease within ≤ 6 weeks of completion of the treatment) of either sex between 18-70 years of age.
- •Patient willing to participate in the study by giving informed written consent.
排除标准
- •Patients with known hypersensitivity / contraindications to azole group of drugs.
- •Patients currently on any other antifungal medications (systemic/topical).
- •Patients on topical corticosteroid therapy in the past two weeks.
- •Patients on/ requiring prolonged therapy with proton pump inhibitors.
- •Patients with pulmonary/extrapulmonary tuberculosis on treatment with anti-tubercular drug regimen involving rifampicin.
- •Patients with concomitant therapy with carbamazepine, phenobarbitone, phenytoin.
- •Patients with baseline ALT more than 3 times of upper limit of normal level.
- •Patients with known heart failure or on any drugs for cardiac arrhythmias
- •Pregnant and lactating females.
- •Patients with history of lactose intolerance.
结局指标
主要结局
• Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy.
时间窗: 8 weeks
-Clinical cure is defined as Score - 0 in Total Symptom Score.16
时间窗: 8 weeks
-Mycological cure is defined as negative KOH mount at the end of 8 weeks of therapy
时间窗: 8 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
Nusrat Shafiq
PGIMER, Chandigarh