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 range6 Months – 17 Years

SexALL

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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.
✕. Has been using hormonal contraception for less than 3 months.
✕. Is pregnant or currently nursing.
✕. Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
✕. Has received an investigational agent within 30 days prior to Day 0.

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