Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

Head Lice Infestation Clinical Trial

Official title: A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.

All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.

Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.

More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and

14. The maximum study duration for a subject is 16 days. ;

Related Conditions & MeSH terms

• Head Lice Infestation
• Lice Infestations
• Parasitic Diseases

• NCT number: NCT01907490
• Study type: Interventional
• Source: Dr. Reddy's Laboratories Limited
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Completion date: December 2013