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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02097485
Other study ID # Ha03-008
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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