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

Phase 3

Completed

• Conditions: Head Lice Infestation
• Interventions: Drug: Vehicle Lotion; Drug: Abametapir Lotion 0.74% w/w

• Registration Number: NCT02060903
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Disposition First Submitted: 2015-08-25
• Disposition First Submitted QC: 2015-09-09
• Disposition First Posted: 2015-09-25
• Status Verified: 2020-09
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Results First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Lotion	Vehicle Lotion	Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
Abametapir Lotion 0.74% w/w	Abametapir Lotion 0.74% w/w	Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.

Primary Outcome Measures

Name	Time	Method
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.	14 days	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.

Trial Locations

Locations (7)

Radiant reserach Inc.; 🇺🇸 San Antonio, Texas, United States

LSRN Reserach; 🇺🇸 West Palm Beach, Florida, United States

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

Universal Biopharma Reserach INC; 🇺🇸 Dinuba, California, United States

Haber Dermatology; 🇺🇸 Beachwood, Ohio, United States

Impact Clinical Trials; 🇺🇸 Las Vegas, Nevada, United States

McKenzie Medical Center; 🇺🇸 McKenzie, Tennessee, United States