Conditions: Head Lice Infestation
Keywords: Head Lice Hatchtech
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 379
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. arm 2: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.

Interventions: intervention 1: Abametapir Lotion 0.74% w/w intervention 2: Vehicle Lotion
Intervention descriptions: intervention 1: Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day. intervention 2: Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.

Protocol document: