Effectiveness and Safety of Spinosad 0.9 percent Topical Solution vs Permethrin 1 percent Topical Solution vs Ivermectin 0.5 percent Topical Lotion in the Treatment of Pediculosis humanus capitis (head lice) Infestation: A Prospective, Comparative, Three arm, Double blind, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of subjects within each treatment group who are lice free (without live lice) at the end of study.
研究概览
简要总结
This is a prospective, comparative, three-arm, double-blind, randomized controlled study designed to assess the effectiveness and safety of three different topical treatments for head lice (Pediculosis humanus capitis) infestation. Subjects with head lice will be randomly assigned in a 1:1:1 ratio to one of three groups: Arm A (Spinosad), Arm B (Permethrin), or Arm C (Ivermectin). The study is double-blind, meaning neither the subjects nor the researchers will know which treatment is being given. On Day 1, a single application of the assigned medication will be applied to the dry hair and scalp, left on for 10 minutes, and then rinsed off. The primary objective is to compare the effectiveness of the three treatments in eradicating head lice infestation. The secondary objective is to evaluate the safety profile of each medication by monitoring for any adverse reactions in the subjects.
This study will provide valuable, evidence-based data on the relative efficacy and safety of three common head lice treatments. The findings can help healthcare professionals make more informed decisions when prescribing treatment, especially in regions where resistance to older medications like permethrin is a concern. The results will also contribute to a better understanding of the overall safety of these medications, which is crucial for public health, particularly for children who are the most common sufferers of head lice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 6.00 Month(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must have an active head lice infestation of at least three live lice and/or viable nits.
- •(Viability of nits to be determined by using magnifying lens at a distance of less than 0.6 cm from the scalp).
- •Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24 hour post treatment evaluation has been completed.
- •Subjects agree not to cut or chemically treat their hair while participating in the study.
- •Subject and/or parent/guardian agree that the subject will not use any other form of lice treatment during the duration of the study.
- •Subjects who are willing to sign informed consent for participation in the study.
- •Subjects who are willing to sign informed assent for participation in the study.
排除标准
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •Scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g. psoriatic scalp lesions, extensive seborrheic dermatitis).
- •Treatment for head lice (OTC, home remedy and/or prescription drugs) in the last 7 days.
- •Subject who used any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days of randomization.
- •Known history of irritation or sensitivity to pediculicides or hair care products.
- •Subjects with known allergy or hypersensitivity to Spinosad/Permethrin/Ivermectin or any component of the test product.
- •Subjects who are a known case of epilepsy or any neurological disorder.
- •Subject receiving any other treatment which may interfere with the study results.
- •Participation in a previous investigational drug study within the past 30 days.
- •Does not understand the requirements for study participation and/or may likely exhibit poor compliance.
结局指标
主要结局
Proportion of subjects within each treatment group who are lice free (without live lice) at the end of study.
时间窗: Subjects are assessed on day 1 (baseline) and on day 14 for the presence of live lice.
次要结局
- Proportion of subjects within each treatment group who are free from viable nits at the end of study.(Subjects are assessed on day 1 (baseline) and on day 14 for the presence of viable nits.)
- Proportion of subjects within each treatment group with improvement in Pruritus score at the end of study compared to baseline.(Pruritis assessment scoring is done at the baseline (day 1) and at the end of the study (day 14))
研究者
Dr Deepadarshan K
Mandya institute of medical sciences, Mandya