Cure, Sleep and Treatment Satisfaction With Topical Sulfur 7% Versus Permethrin 5% in Scabies: A Randomized Open-Label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Complete cure rate at week 2
研究概览
简要总结
This study compares two creams used to treat scabies, a common skin condition caused by mites that causes intense itching. Ninety adults with scabies were randomly assigned to receive either sulfur 7% cream or permethrin 5% cream. Sulfur cream was applied once each evening for three nights in a row; permethrin cream was applied once, left on overnight, and repeated after one week. Participants were examined after two weeks and again after four weeks to see whether the scabies had cleared.
The study also looked at how quickly itching improved, how much sleep improved, how satisfied participants were with each treatment, how many side effects occurred, and how much each treatment cost. The goal is to help doctors and patients choose between these two widely available, inexpensive treatments based on real-world evidence of how well each one works and how well it is tolerated.
详细描述
Scabies is a highly pruritic skin infestation caused by Sarcoptes scabiei that remains endemic in many resource-limited settings. Permethrin 5% cream is recommended as first-line topical therapy in most international guidelines, but sulfur-based preparations remain widely used because of their low cost and long safety record, particularly in settings where permethrin is expensive or unavailable. Head-to-head comparative data between these two agents, especially data incorporating patient-centered outcomes such as sleep and treatment satisfaction, are limited.
This was a randomized, open-label trial conducted at Can Tho Dermatology Hospital, Can Tho City, Vietnam, enrolling 90 adults aged 18 years or older with a clinical diagnosis of ordinary (non-crusted) scabies, established using the 2020 International Alliance for the Control of Scabies (IACS) consensus criteria. Participants were randomly allocated in a 1:1 ratio to one of two treatment arms. In the sulfur arm, sulfur 7% cream was applied from the neck to the soles each evening, left on for 8-14 hours, and washed off, for three consecutive days. In the permethrin arm, permethrin 5% cream was applied in the same manner as a single overnight application, repeated once after seven days. Both groups received standardized instructions on decontamination of clothing, bedding and towels, and household contacts were offered the same regimen.
Participants were evaluated at baseline, week 2, and week 4. The primary outcome was complete cure, defined according to the 2017 European guideline as resolution of pruritus with no active or new lesions on examination. Secondary outcomes included pruritus severity (verbal rating scale), sleep quality and insomnia symptoms (Athens Insomnia Scale), treatment satisfaction (9-item Treatment Satisfaction Questionnaire for Medication), adverse events, and direct treatment cost. Associations between improvement in itching and improvement in sleep were also examined. Because outcome data were not normally distributed, between-group and within-group comparisons used non-parametric methods (Mann-Whitney U, Wilcoxon signed-rank, chi-square or Fisher's exact test, and Spearman rank correlation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Clinical diagnosis of ordinary (non-crusted) scabies, established using the 2020 International Alliance for the Control of Scabies (IACS) consensus criteria, category B:
- •B1: burrow identified, or
- •B2: typical lesions at male genitalia, or
- •B3: typical lesions at typical sites plus pruritus and a history of close contact with a person with scabies or itch
排除标准
- •Known allergy or intolerance to sulfur or permethrin
- •Pregnant or breastfeeding women
- •Hearing, visual, or cognitive impairment preventing reliable self-reporting of symptoms
- •Self-discontinuation of study treatment before completion
研究组 & 干预措施
Arm 1 (Sulfur 7%)
Intervention Type: Drug Intervention Name: Sulfur 7% cream Description: Applied from neck to soles once each evening, left on for 8-14 hours then washed off, for 3 consecutive days.
Arm/Group Label: Sulfur 7%
干预措施: Sulfur 7% cream (Drug)
Arm 2 (Permethrin 5%)
Intervention Type: Drug Intervention Name: Permethrin 5% cream Description: Applied from neck to soles as a single overnight application (8-14 hours), repeated once after 7 days.
Arm/Group Label: Permethrin 5%
干预措施: Permethrin 5% cream (Drug)
结局指标
主要结局
Complete cure rate at week 2
时间窗: Week 2 after treatment initiation
Proportion of participants achieving complete cure using the same definition as above, assessed at the earlier time point.
Complete cure rate at week 4
时间窗: Week 4 after treatment initiation
Proportion of participants achieving complete cure, defined per the 2017 European guideline as resolution of pruritus with no active lesions and no new lesions on clinical examination.
次要结局
- Change in pruritus severity(Baseline, week 2, week 4)
- Change in insomnia symptoms (Athens Insomnia Scale)(Baseline, week 2)
- Insomnia prevalence(Baseline, week 2)
- Treatment satisfaction(Week 4)
- Incidence of treatment-related adverse events(Through week 4)
- Direct treatment cost(Week 4)
- Correlation between itch reduction and sleep improvement(Week 2)
研究者
Tran Gia Hung
Lecturer, Department of Dermato-Venereology, Faculty of Medicine
Can Tho University of Medicine and Pharmacy