NCT07660354招募中不适用
In Vivo Testing : A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety, Efficacy, and Preventative Effect of a Head Lice Physically Acting Product: 2 in 1 SHAMPOO EU VERSION (X92001483) vs NIX CREME RINSE (1% Permethrin) in Subjects With Head Lice.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
研究概览
简要总结
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
详细描述
Compare Safety, Efficacy and preventative effect of a medical device with a physical mode of action against Nix Cream Rinse (1% Permethrin) in Subjects with Head Lice in a two-arm, randomized, controlled, Investigator/Assessor-blinded comparative study.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: male / female.
- •The subject or his/her parent/legal guardian (from age 12-17) must give written informed consent (after having been informed orally and by written text about the benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study). A caregiver must sign an informed consent agreement for children not old enough to do so. Children aged 6-11 years of age will be administered a child's assent form. The subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
- •Age ≥ 1 year of age at the time of enrollment.
- •Subject agree to not use any other anti-lice or preventative treatment or medicated hair grooming products for the duration of the study (through last visit day- Day 14).
- •Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 live nits based on magnified observations, present on the scalp and/or hair, as determined by a trained evaluator.
- •The subject is in good general health based on medical history.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a reliable method of birth control (as described in section 7.8) during duration of the study.
- •The parent or legal guardian of a child subject must consent to the screening of other household members for head lice. If additional household members are found to have head lice and meet eligibility criteria, they must be enrolled in the study for all household members to qualify for participation.
- •Have a single place of residence or agree to remain at the current residence for the duration of the study.
- •Subject agrees not to additionally shampoo, wash, or rinse their hair or scalp for 24-hours post treatment.
- •The subject agrees not to cut or chemically treat their hair while participating in the study.
- •Subject agrees to follow all study instructions, including attending all follow-up appointments.
排除标准
- •Application of any form of head lice treatment, whether prescription or over-the counter (OTC), or home remedy for 14 days prior to their screening visit (Visit 1).
- •Application of any topical medication of any kind on the hair or scalp for a period of 48 hours prior to the screening visit.
- •Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
- •Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
- •History of allergy or hypersensitivity to active ingredients, or constituents of the investigational or comparator products.
- •Subject with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation of the investigational product.
- •Subjects with chronic scalp disorder.
- •Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/or may be likely to exhibit poor compliance with the required visits.
- •Females who are pregnant or nursing.
- •Hair longer than waist length.
- •Subject suspected or known not to follow instructions
- •Previous participation in this study or participation in any other investigational trial within the preceding 14 days.
- •The subject is directly affiliated to the investigator site personnel and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •The subject is an Oystershell employee or is an employee of a third-party organization involved in the study.
- •People with dreadlocks or clips in hair that cannot be removed or a person who does not want to remove these.
- •Hair that is too difficult to work with as assessed by the study staff.
- •Families excluded where lice exist however a family member decline enrollment in the study.
- •Subjects who are receiving, or are expected to receive, any antibiotic therapy during the study period will be excluded.
- •No more than one working male subject per household may be excluded from evaluation if determined to be lice free by self-report or caregiver observation.
- •All household members of the subject, other than excluded male adult, must be screened for head lice by a certified head lice professional. If additional household members are found to have head lice and meet the study criteria, they will be referred to LSRN Research and enrolled in study. If a household member declines enrollment, all family members will be excluded from the study.
研究者
研究点 (1)
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