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

NCT02060903 | Completed Phase 3 Results

• 1 other identifier: Ha03-001
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 7

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.

Conditions

Head Lice Infestation

Keywords

Head Lice; Hatchtech

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Abametapir Lotion 0.74% w/w

ACTIVE COMPARATOR

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

Vehicle Lotion

PLACEBO COMPARATOR

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

Drug: Vehicle Lotion

Interventions

Abametapir Lotion 0.74% w/w DRUG

Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.

Also known as: Abametapir 0.74%

Abametapir Lotion 0.74% w/w

Vehicle Lotion DRUG

Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.

Also known as: Vehicle

Vehicle Lotion

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged six months of age or older.
• Is in good general health based on medical history.
• 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.
• The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
• Belongs to a household with an eligible index subject with active head lice infestation.
• Agrees to an examination for head lice and to all visits and procedures throughout the study.
• Has signed an informed consent and/or assent form.

You may not qualify if:

• Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
• 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.
• Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
• Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
• Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
• Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
• 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.
• Has eczema or atopic dermatitis of skin/scalp.
• Has had a prior reaction to Nix® or products containing permethrin.
• Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
• Has received an investigational agent within 30 days prior to Day 0.
• 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).

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• Accelovance: collaborator
• Syneos Health: collaborator

Study Sites (7)

Universal Biopharma Reserach INC

Dinuba, California, 93618, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

LSRN Reserach

West Palm Beach, Florida, 33407, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

Haber Dermatology

Beachwood, Ohio, 44122, United States

Location

McKenzie Medical Center

McKenzie, Tennessee, 38201, United States

Location

Radiant reserach Inc.

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Dr. Srinivas Sidgiddi
• Organization: Dr. Reddy's Laboratories Inc.

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Srinivas Sidgiddi, MD

  Dr. Reddy's Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 23, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-09

Locations

US (7)