Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.

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Detailed Description

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This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy 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 the study site. This study used an ex vivo method of assessment for ovicidal efficacy.

Conditions

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Head Lice Infestation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Abametapir Lotion 0.74% w/w

Topically administered to hair and scalp for 10 minutes application.

Group Type ACTIVE_COMPARATOR

Abametapir Lotion 0.74% w/w

Intervention Type DRUG

200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.

Vehicle Lotion

Administered to scalp and hair for 10 minutes application.

Group Type PLACEBO_COMPARATOR

Vehicle Lotion

Intervention Type DRUG

control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.

Interventions

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Abametapir Lotion 0.74% w/w

200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.

Intervention Type DRUG

Vehicle Lotion

control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male or female based on medical history
2. Six months of age or older.
3. Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
4. Agrees to an examination for head lice and compliance with the study procedures.
5. All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.

Exclusion Criteria

1. Has scalp disease or a history of allergies or prior reactions to any head lice products.
2. Has a condition that, in the opinion of the Investigator, may interfere with the study.
3. Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
4. Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0.
5. Has received an investigational agent within 30 days prior to Day 0.

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No