CTRI/2018/10/016125尚未招募3 期
A Comparative, Two arm, Randomized, Double blind, Parallel Group, Vehicle Controlled Clinical Study to Evaluate Efficacy and Safety of Ivermectin Lotion 0.5% w/w for the Treatment of Pediculus humanus capitis (head lice) Infestation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 219
- 试验地点
- 16
- 主要终点
- To evaluate the efficacy of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects.
研究概览
简要总结
A Comparative, Two arm, Randomized, Double blind,Parallel Group, Vehicle Controlled Clinical Study to Evaluate Efficacy andSafety of Ivermectin Lotion 0.5% w/w for the Treatment of Pediculus humanus capitis (head lice) Infestation
PrimaryObjective: To evaluate the efficacy of Ivermectin Lotion 0.5% w/wVersus Vehicle Control in lice infested subjects.
SecondaryObjective: To evaluate the safety of Ivermectin Lotion 0.5% w/wVersus Vehicle Control in lice infested subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects meeting all of the following criteria will be recruited for the trial: 1.Healthy males, non-pregnant females and children of age ≥6 months to ≤65 years (both inclusive) will be enrolled.
- •2.Subjects must have an active head lice infestation of atleast 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/6 mm from the scalp).
- •3.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.
- •4.Subject agrees not to cut or chemically treat their hair while participating in the study.
- •5.Subject and/or parent/guardian agree that the subject will not use any other form of lice treatment during the duration of the study.
- •6.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- •Caregivers who are willing to sign Informed Consent agreement for children of age <7 years.
- •Children of age ≥7 years who are willing to sign a child’s assent form.
排除标准
- •Subjects will be excluded if ANY of the following conditions apply: 1.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.
- •2.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).
- •3.Treatment for head lice (OTC, home remedy and/or prescription drugs) in the last 7 days.
- •4.Subject who used any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days of randomization.
- •5.Known history of irritation or sensitivity to pediculicides or hair care products.
- •6.Subjects with known allergy or hypersensitivity to Ivermectin or any component of the test product.
- •7.Any condition or illness that may compromise the objective of the protocol.
- •8.Subject receiving any other treatment which may interfere with the study results.
- •9.Participation in a previous investigational drug study within the past 30 days.
- •10.Does not understand the requirements for study participation and/or may likely exhibit poor compliance.
结局指标
主要结局
To evaluate the efficacy of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects.
时间窗: at the end of 2 weeks
次要结局
- To evaluate the safety of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects(at the end of 2 weeks)
研究者
研究点 (16)
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