CompletedPhase 2

A Pilot Dose Ranging Study of Spinosad Creme Rinse

United States36 participantsStarted 2005-09

Plain-language summary

A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Active head lice infestation * Male or female, 2 years of age or older * Good general health * Appropriately signed Informed Consent * Subject agreement to not use any other form of lice treatment during the course of the study * Subject agreement to not cut or chemically treat their hair between visits Exclusion Criteria: * History of irritation or sensitivity to pediculicides or hair care products * Individuals with any visible skin/scalp condition that would interfere with the evaluation * Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment * Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment * Individuals who have participated in any clinical trial within 30 days of enrollment * Individuals with family members who were infested with lice but were unwilling or unable to enroll in the study or use a standard course of lice treatment * Females who were pregnant or nursing * Sexually active females not using effective contraception

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.

Timeframe: 14 days

Trial details

NCT IDNCT00858481

SponsorParaPRO LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-11

View on ClinicalTrials.gov More Pediculosis Capitis trials

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.