Back to resultsOvicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Primary Purpose
Head Lice Infestation
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Abametapir Lotion 0.74% w/w
Vehicle Lotion
Sponsored by
About this trial
This is an interventional treatment trial for Head Lice Infestation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Head Lice Treatment Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Abametapir Lotion 0.74% w/w
Vehicle Lotion
Arm Description
Topically administered to hair and scalp for 10 minutes application.
Administered to scalp and hair for 10 minutes application.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02097485
First Posted
March 24, 2014
Last Updated
April 19, 2021
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT02097485
Brief Title
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice Infestation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abametapir Lotion 0.74% w/w
Arm Type
Active Comparator
Arm Description
Topically administered to hair and scalp for 10 minutes application.
Arm Title
Vehicle Lotion
Arm Type
Placebo Comparator
Arm Description
Administered to scalp and hair for 10 minutes application.
Intervention Type
Drug
Intervention Name(s)
Abametapir Lotion 0.74% w/w
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle Lotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Arnold, MBBS
Organizational Affiliation
National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Head Lice Treatment Centre
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
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