CompletedPhase 2

Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

38 participantsStarted 2013-03

Plain-language summary

The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions. Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.

Who can participate

Age range

6 Months – 17 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

. Male or female
. 6 months to 17 years of age
. Be in good health, as determined by medical history and physical examination
. Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.
. Female subjects must be:
. The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
. Has signed an informed consent and/or assent form (ICF).

Exclusion criteria

. Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
. Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
. Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.

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

Number of the Subjects With AEs.

Timeframe: 3 months

Trial details

NCT IDNCT01907490

SponsorDr. Reddy's Laboratories Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2015-01-12

View on ClinicalTrials.gov More Head Lice Infestation trials