NCT02010333

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 6 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head Lice Infestation

Interventions

Type	Name	Description
DRUG	Ha44 Gel 0.74% w/w	HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2013-12-12
• Last updated: 2020-05-12

Locations

2 sites across 1 country: United States