A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
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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.
Safety and tolerability of Ha44 Gel [ Time Frame: 8 months ]
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
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Ages Eligible for Study:
6 Months to 2 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female, 6months < 3years of age
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
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.