Effectiveness and Safety of Spinosad 0.9 Percent Topical Solution vs Permethrin 5 Percent Topical Solution in the Treatment of Scabies: A Prospective, Comparative, Two arm, Double blind, Randomized Controlled Study at a Tertiary Care Centre in Mandya.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of subjects within each treatment group showing complete clinical cure defined as reduction in both the number of lesions as well as the grade of pruritus by more than or equal to 50% and negative dermatoscopy.
研究概览
简要总结
This study is a prospective, double-blind, randomized controlled trial comparing Spinosad 0.9% topical solution and Permethrin 5% cream in the treatment of scabies.
A total of 60 patients with clinically and dermatoscopically confirmed scabies will be enrolled and randomly allocated into two groups.
Each participant will receive a single application of either Spinosad or Permethrin, with follow-up assessments at 1, 2, and 4 weeks.
Effectiveness will be measured by reduction in lesions, pruritus severity, and dermatoscopic cure, while safety will be monitored through adverse events.
The primary objective is to compare complete clinical cure rates between the two drugs.
The findings aim to provide evidence on whether Spinosad can serve as an effective and safe alternative to Permethrin in routine scabies management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 5 years or older, either gender with active scabies infestation showing the presence of scabies inflammatory lesions (papules, pustules, vesicles, excoriations), pruritus and confirmed with burrows or mite or eggs in dermatoscopy.
- •Patient (or their legal guardians) are willing to give the informed consent/ assent to participate in the study.
排除标准
- •Pretreatment with topical or oral scabicide in the previous 4 weeks.
- •Use of topical steroids or topical immunosuppressives within 2 weeks.
- •Patients having scabies with secondary infection or eczematization and coexisting dermatological disease that could interfere with the diagnosis and subsequent monitoring of scabies.
- •Patients with immunodeficiency or severe systemic disease.
- •Pregnant, planning for pregnancy during the study and lactating females.
- •Patients with known hypersensitivity to the drugs.
结局指标
主要结局
Proportion of subjects within each treatment group showing complete clinical cure defined as reduction in both the number of lesions as well as the grade of pruritus by more than or equal to 50% and negative dermatoscopy.
时间窗: Dat 14
次要结局
- Proportion of patients showing reduced number of lesions/ symptoms.(Proportion of patients showing recurrence of lesions)
研究者
Dr Deepadarshan K
Mandya Institute Of Medical Sciences