Comaparative study of efficacy and tolerability of topical therapy with 0.25% Amorolfine cream versus 1% Luliconazole cream in patients of tinea corporis: A randomized, parallel group, open-label study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving clinical improvement/cure at 4 weeks (the end of treatment period) w.r.t. Physician Global Assessment Scale(absence of signs and symptoms such as erythema, scaling, and pruritus)
研究概览
简要总结
1.Title of the study: Comparative study of efficacy and tolerability of topical therapy with 0.25% Amorolfine cream versus 1%luliconazole cream in patients of tinea corporis A randomized parallel group open label study
2.Introduction: Dermatophytosis is a common superficial fungal infection caused by keratinophilic fungi primarily affecting keratinized tissues like skin hair and nails It is most prevalent in tropical and subtropical countries due to hot and humid climate
3.Objective:
a)Primary: To compare the efficacy of 0.25% Amorolfine cream and 1% luliconazole cream in the treatment of tinea corporis
b)secondary: (i)To compare the tolerability of 0.25% Amorolfine cream and 1% luliconazole cream in the treatment of tinea corporis
(ii)To compare the improvement in Dermatology Life Quality Index (DLQI) between 2 percent naftifine cream and 1 percent luliconazole cream in the treatment of tinea corporis
4.Study design: Randomized parallel group open label study
5.Study setting: Conducted at the outpatient department of Dermatology Venereology and Leprosy
6.Study population: Patients with clinically diagnosed tinea corporis meeting inclusion and exclusion criteria
7.Sample size: 90 patients
8.Intervention: Group A will receive 0.25% Amorolfine cream once daily for two weeks Group B will receive 1% luliconazole cream once daily for two weeks
9.Control group: Not applicable as both groups receive active interventions
10.Duration: Two weeks of treatment with follow up at the end of therapy and after two weeks post treatment
11.Outcomes:
a)Primary outcome: Clinical and mycological cure rates at the end of therapy
b)Secondary outcomes: Adverse effects and recurrence rates at follow up
12.Data collection: Clinical assessment and mycological evaluation will be performed at baseline end of therapy and follow up
13.Statistical analysis: Data will be analyzed using appropriate statistical methods to compare efficacy and tolerability between groups
14.Ethical considerations: The study will be conducted after obtaining approval from the Institutional Ethics Committee and informed consent from all participants
15.Expected impact: The study aims to provide comparative data on the effectiveness and safety of two topical antifungal agents which may guide clinicians in selecting appropriate therapy for tinea corporis
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 with clinical manifestations of tinea corporis 2)Patients of 18-70 years of age.
- •Subjects of either gender.
- •Subject willing to give written informed consent.
- •Patients having a physician global assessment (PGA) composite score of at least 5 (composite score is a combined score of all clinical signs and symptoms of tinea infection).
排除标准
- •Patients having clinical diagnosis of tinea infections other than tinea corporis 2)Patients having extensive fungal infection 3)Patients who had received topical or oral antifungal agents up to 4 weeks before the initiation of the study 4)History of hypersensitivity to the study drugs 5)Patients who are known cases of compromised immune status 6)Patients having superadded bacterial infection 7)Pregnant or lactating women.
结局指标
主要结局
Proportion of patients achieving clinical improvement/cure at 4 weeks (the end of treatment period) w.r.t. Physician Global Assessment Scale(absence of signs and symptoms such as erythema, scaling, and pruritus)
时间窗: Proportion of patients showing improvement/clinical cure will be assessed at Week 2 and Week 4
次要结局
- Tolerability assessment evaluated by systematically recording and assessing all spontaneously reported adverse events from participants during the 4 week treatment period(1. Baseline (start of treatment))
- Proportion of patients showing improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI) questionnaire.(The DLQI questionnaire will be filled by the patient at the following time points:)
研究者
Dr Shubham Nimbhorkar
Government Medical College, Nagpur