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Completed

NCT Number: NCT02010333

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

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.

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Key information

Conditions

Head Lice Infestation

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universal Biopharma Research Institute, Dinuba, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Ha44 Gel 0.74% w/w

Drug

HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.

Other names: Abametapir 0.74%, Benzyl Alcohol

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dr. Reddy's Laboratories Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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