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

NCT02097485 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Ha03-008
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head Lice Infestation

Outcome Measures

Primary Outcomes (1)

• Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment

  Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent.

  14 days

Study Arms (2)

Abametapir Lotion 0.74% w/w

ACTIVE COMPARATOR

Topically administered to hair and scalp for 10 minutes application.

Drug: Abametapir Lotion 0.74% w/w

Vehicle Lotion

PLACEBO COMPARATOR

Administered to scalp and hair for 10 minutes application.

Drug: Vehicle Lotion

Interventions

Abametapir Lotion 0.74% w/w 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.

Abametapir Lotion 0.74% w/w

Vehicle Lotion 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.

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:

• Healthy male or female based on medical history
• Six months of age or older.
• 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.
• Agrees to an examination for head lice and compliance with the study procedures.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

National Head Lice Treatment Centre

Ringwood East, Victoria, 3135, Australia

Location

Results Point of Contact

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

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Scott Arnold, MBBS

  National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: March 24, 2014
• First Posted: March 27, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

AU (1)