Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides (NCT00758823) | Clinical Trial Compass
CompletedNot Applicable
Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides
India750 participantsStarted 2008-08
Plain-language summary
THe main goal of our randomized controlled trial with blinded observer will be to compare four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority (20% equivalence). THe randomization will be balanced every 10 families. The secondary objective will be to compare the lenticide efficacy of the products and their local tolerance and cosmetic acceptibility.
Who can participate
Age range
3 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:
* Subject-male or female, child \> 3 years and adult
* Pediculosis of scalp, confirmed by the identification of minimum 5 live lice with a fine-tooth comb
* Negative urine pregnancy test before inclusion for women of childbearing potential
* Use of a contraceptive method by hormonal contraceptives or IUDs or tubal ligation or condoms for women of childbearing potential
* Subject agreeing to participate in the study with written informed consent for participation
* Written consent of both parents for the minor patients.
Exclusion Criteria:
* Children under 3 years.
* Woman pregnant or lactating or without contraception
* Use of a pediculicide or lenticide treatment within 2 weeks before entry into the study
* Subject with known hypersensitivity to any component of the tested products
* Subject who participated in a clinical study in the 3 months prior to inclusion
* Ongoing treatment potentially interacting with the treatment under study (other pediculicide products)
* Subject undertreatment susceptible to influence the evaluation of the trial (including trimethoprim-sulfamethoxazole).
* Severe medical or psychiatric illness considered by the investigator as potentially dangerous to the subject or incompatible with the conduct of the study
* Asthma
* Subject unable for linguistic or psychiatric reasons to understand the information and give informed consent
* Subject refusing to give written consent
* Subject deprived of his liberty by administrative or …
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
1
statistical analysis will compare the number of successes and failures for each products