Comparing Sulfur to Different Regimes of Permethrin for the Treatment of Scabies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Clinical Recovery
研究概览
简要总结
In 2017, the World Health Organization (WHO) labeled scabies as a neglected tropical disease. It is a serious health problem especially in poor developing countries like Syria, where overcrowding, poverty, and war consequences are considered major factors for spreading the disease. Permethrin lotion or cream is the treatment of choice for scabies, and it is applied once a week for two consecutive weeks according to the global guidelines. However, most practitioners in Syria do not adhere to this standard regimen, and a variety of regimens are used instead based mostly on clinical experience. In this study, the investigators are comparing four different regimens of permethrin application and comparing Sulfur to permethrin in terms of efficacy and safety.
详细描述
Background:
In 2017, the World Health Organization (WHO) labeled scabies as a neglected tropical disease that affects more than 200 million people at any time. Treating scabies in developing countries constitutes a major challenge because of factors like poverty, overcrowded areas, inadequate disease education, and low adherence to proper therapy, which together can contribute to treatment failure and the spread of the disease.
These factors abundantly exist in Syria as it is considered a developing, low-income country. Moreover, the long-term Syrian war added a significant negative impact to the socio-economic status and prevalence of scabies, raising the difficulty in controlling the disease.
Several treatment options may be used for classic scabies including permethrin 5%, crotamiton 10%, sulfur (5-10%) ointment, lindane 1%, and ivermectin. There is no ideal scabicide because the treatment choice changes according to the patient's situation, and any one of the previous agents may be used alone or in combination.
Permethrin 5% lotion or cream is the treatment of choice for scabies based on a 2007 updated Cochrane review. Most of the treatment guidelines in developing countries recommend applying the drug once a week for 8-14 hours and repeating the application after seven days. According to what is published in the medical literature, this regimen of permethrin application is usually effective and sufficient without significant drug resistance yet.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scabies participants who meet "The 2020 International Alliance for the Control of Scabies (IACS) Consensus Criteria" level A or B.
- •Participants can apply the treatment themselves or by their guardians if they are children.
- •Participants willing to commit to the study's requirements
排除标准
- •Participants are younger than two years.
- •Participants with other skin diseases that could interfere with their assessment.
- •Participants who received treatment for scabies in the preceding month.
- •Receiving treatment with corticosteroids in the preceding week.
- •Pregnancy, planning for pregnancy during the study, or breastfeeding.
- •Systemic infection or receiving systemic therapy for an infectious disease
- •Immunocompromised Participants.
- •Participants with crusted/Norwegian scabies.
- •Having sensitivity or allergy to permethrin or sulfur.
- •Participants with abnormal liver and kidney functions, thyroid disease, cardiac disorders, psychiatric illnesses.
- •Participation of a family member, or another member of the household in the current study.
- •The number of participants' households is seven or more.
研究组 & 干预措施
Arm P1
Permethrin 5% solution
Participants randomly assigned to this group will apply the solution once, leave it on for ≥ 8 hours, rinse it, then reapply it the same way on day 8.
干预措施: Permethrin Solution (Drug)
Arm P2
Permethrin 5% solution
Participants randomly assigned to this group will apply the solution on days one, two, and three -for ≥ 8 hours each day- then rinse it (without rinsing in between these days) and reapply it on days eight, nine, and ten then rinse it.
干预措施: Permethrin Solution (Drug)
Arm P3
Permethrin 5% solution
Participants randomly assigned to this group will apply the solution on days one, two, and three -for ≥ 8 hours each day- then rinse it (without rinsing in between these days). They will reapply it on day eight and rinse it after ≥ 8 hours.
干预措施: Permethrin Solution (Drug)
Arm P4
Permethrin 5% solution
Participants assigned to this group will apply the solution on the first two days in the first week (for ≥ 8 hours each day with rinsing in between these days) and reapply it on day eight and rinse it after ≥ 8 hours.
干预措施: Permethrin Solution (Drug)
Arm S
Sulfur 10%+ vaseline 90 % ointment
Participants assigned to this group will apply the ointment for three consecutive days (for ≥ 8 hours each day and without rinsing in between these days).
干预措施: Sulfur (Drug)
结局指标
主要结局
Clinical Recovery
时间窗: At day 14 and 28 following the intervention.
Clinical recovery is defined as: * Absence of new scabietic skin lesions, AND * All remaining scabietic lesions are in healing, AND * Improvement of itch, defined by a decrease in itching grading score up to grade 0, 1, or 2 or a decrease for one grade, as for the participants who were diagnosed as grade 2 or less from the first visit. The variable is binary: Yes or No.
次要结局
- Rate of adverse events(At day 14 and 28 following the intervention.)
- Verbal rating scale of pruritus(At day 14 and 28 following the intervention.)