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

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.

Study Overview

• Status: Completed
• Conditions: Head Lice Infestation
• Intervention / Treatment: Drug: Abametapir Lotion 0.74% w/w; Drug: Vehicle Lotion

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.

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Dinuba, California, United States, 93618
      • Universal Biopharma Reserach INC
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • LSRN Reserach
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Impact Clinical Trials
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Haber Dermatology
  • Tennessee
    • McKenzie, Tennessee, United States, 38201
      • McKenzie Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Radiant reserach Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, aged six months of age or older.
2. Is in good general health based on medical history.
3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
5. Belongs to a household with an eligible index subject with active head lice infestation.
6. Agrees to an examination for head lice and to all visits and procedures throughout the study.
7. Has signed an informed consent and/or assent form.

Exclusion Criteria:

1. Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
7. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.
8. Has eczema or atopic dermatitis of skin/scalp.
9. Has had a prior reaction to Nix® or products containing permethrin.
10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
11. Has received an investigational agent within 30 days prior to Day 0.
12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Abametapir Lotion 0.74% w/w; Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.	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.; Other Names: Abametapir 0.74%
PLACEBO_COMPARATOR: Vehicle Lotion; Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.	Drug: Vehicle Lotion; Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.	Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit.	14 days

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Collaborators: Syneos Health; Accelovance

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (ESTIMATE): February 12, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Head Lice; Hatchtech
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Parasitic Diseases; Mite Infestations
• Other Study ID Numbers: Ha03-001