A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation

Completed · Phase 2

Conditions studied: Head Lice Infestation

In brief

The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.

Key facts

Study ID

NCT02010333

Run by

Dr. Reddy's Laboratories Limited

People needed

22

Starts

2013-04-01

Expected to finish

2014-08-01

Last updated by the study team

2020-05-12

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 6months < 3years of age
• Good health
• Active head lice infestation defined as the presence of at least 3 live lice
• Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
• Parent/guardian agrees to allow PK samples collected
• Signed Informed Consent Form

You may not qualify if…

• Condition or illness that in the opinion of the investigator may interfere with the study results.
• Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
• Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
• Receiving systemic or topical medication that may interfere the study results.
• Received an investigational agent within 30 days prior to Day 0.

Where it is running

• Universal Biopharma Research Institute — Dinuba, California, United States
• Axis Clinical Trials — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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