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

Head Lice Infestation Clinical Trial

Official title:

A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered for the Treatment of Head Lice Infestation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097485
• Other study ID #: Ha03-008
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: April 2021
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Head Lice Infestation
• Lice Infestations
• Parasitic Diseases

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	National Head Lice Treatment Centre	Ringwood East	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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