NCT02060903

A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.

Detailed description

This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to scalp and hair for 10 minutes at home. Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.

Conditions

• Head Lice Infestation

Interventions

Type	Name	Description
DRUG	Abametapir Lotion 0.74% w/w	Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.
DRUG	Vehicle Lotion	Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2014-02-12
• Last updated: 2020-09-23
• Results posted: 2020-09-23

Locations

7 sites across 1 country: United States