Comparison of Topical Permethrin 5% and Spinosad 0.9% for Scabies Treatment
Comparison of the Efficacy of Topical Permethrin 5% and Spinosad 0.9% in the Treatment of Scabies: A Randomised Controlled Trial
The goal of this randomized controlled clinical trial is to compare the effectiveness of topical Permethrin 5% cream and Spinosad 0.9% suspension in treating scabies in patients aged 5-60 years.
The main questions it aims to answer are:
- Is there a difference in the effectiveness of topical Permethrin 5% and Spinosad 0.9% in treating scabies at Day 14?
- What are the treatment-related adverse effects of these two medications?
Researchers will compare the two treatment groups to determine whether there is a significant difference in treatment efficacy.
Participants will be randomly assigned to one of two groups:
- Group A will receive topical Permethrin 5% cream, applied from the neck to the toes for 8-12 hours, followed by washing. A second application will be given after 7 days.
- Group B will receive topical Spinosad 0.9% suspension, applied similarly, with repeat application only if clinically indicated.
Participants will be instructed regarding correct treatment application, hygiene measures, and treatment of close contacts. They will be assessed at baseline, Day 7, and Day 14.
The main outcome will be treatment efficacy at Day 14, defined as complete resolution of itching, healing of skin lesions, and absence of new lesions.
研究概览
详细说明
Scabies is a common parasitic skin infestation characterized by nocturnal itching and characteristic skin lesions. It can affect the quality of life of patients and may lead to secondary complications.
Topical Permethrin 5% is a standard treatment for scabies. Spinosad 0.9% is a topical ectoparasiticidal agent with a different mechanism of action. This study is designed to compare the efficacy of these two topical treatments in patients with clinically diagnosed scabies.
This study will be conducted as a randomized controlled trial in the Department of Dermatology. A total of 180 patients of either gender, aged 5-60 years, will be enrolled using non-probability consecutive sampling after fulfilling the predefined inclusion and exclusion criteria and providing informed written consent.
Participants will be randomly allocated into two groups using a computer-generated randomization method.
Group A will receive topical Permethrin 5% cream applied from neck to toe for 8-12 hours, followed by washing. A second application will be given after seven days.
Group B will receive topical Spinosad 0.9% suspension applied similarly, with repeat application only if clinically indicated.
Participants will be instructed regarding correct application technique, hygiene measures, and treatment of close contacts. Follow-up assessments will be conducted on Day 7 and Day 14.
Treatment efficacy will be assessed at Day 14 based on complete resolution of pruritus, healing of skin lesions, and absence of new lesions. Clinical response, visual analogue scale for pruritus, number of active lesions, new lesions, and treatment-related adverse effects will also be assessed.
Data will be analyzed using SPSS version 25. The Chi-square test will be used to compare treatment efficacy between the two groups. A p-value of 0.05 or less will be considered statistically significant.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sabeen Riaz, MBBS
- 电话号码：+923157472819
- 邮箱：drsabeenriaz907@gmail.com
研究联系人备份
- 姓名：Tanzeela Khalid, MBBS, FCPS Dermatology
- 电话号码：+923336501571
- 邮箱：tanzeelakhalid@tuf.edu.pk
学习地点
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-
Punjab Province
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Faisalābad、Punjab Province、巴基斯坦、38000
- Madina Teaching Hospital
-
接触：
- Areeba Basharat, MBBS
- 电话号码：+923074396418
- 邮箱：areebabasharat567@gmail.com
-
接触：
- Sabeen Riaz, MBBS
- 电话号码：+923157472819
- 邮箱：drsabeenriaz907@gmail.com
-
首席研究员：
- Sabeen Riaz, MBBS
-
副研究员：
- Areeba Basharat, MBBS
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients of either gender.
- Patients aged 5-60 years.
- Patients presenting with clinically diagnosed scabies, characterized by nocturnal pruritus and characteristic skin lesions such as burrows, papules, or nodules.
Exclusion Criteria:
- Patients with secondary bacterial infection requiring systemic antibiotics.
- Patients who have received anti-scabies treatment within the last four weeks.
- Patients with known hypersensitivity to permethrin or spinosad.
- Pregnant or lactating women.
- Patients with chronic dermatological conditions that may interfere with assessment.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group A - Permethrin 5%
Patients randomized to Group A will receive topical Permethrin 5% cream applied from neck to toe for 8-12 hours, followed by washing. A second application will be given after 7 days. |
Patients will receive topical Permethrin 5% cream applied from neck to toe for 8-12 hours followed by washing. A second application will be given after 7 days. |
|
实验性的：Group B - Spinosad 0.9%
Patients randomized to Group B will receive topical Spinosad 0.9% suspension applied similarly. Repeat application will be performed only if clinically indicated. |
Patients will receive topical Spinosad 0.9% suspension. Repeat application will be performed only if clinically indicated. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants achieving treatment efficacy at day 14
大体时间：Day 14 after treatment initiation
|
Treatment efficacy will be defined as complete resolution of pruritus, healing of skin lesions, and absence of new lesions at day 14 after treatment initiation, as determined by clinical examination and patient-reported symptoms. The proportion of participants achieving treatment efficacy will be compared between the permethrin 5% and spinosad 0.9% groups. |
Day 14 after treatment initiation
|
合作者和调查者
调查人员
- 研究主任：Tanzeela Khalid, MBBS, FCPS Dermatology、The University of Faisalabad
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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