Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02097485 |
Recruitment Status :
Completed
First Posted : March 27, 2014
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head Lice Infestation | Drug: Abametapir Lotion 0.74% w/w Drug: Vehicle Lotion | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | May 2014 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Abametapir Lotion 0.74% w/w
Topically administered to hair and scalp for 10 minutes application.
|
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. |
Placebo Comparator: Vehicle Lotion
Administered to scalp and hair for 10 minutes application.
|
Drug: 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. |
- Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment [ Time Frame: 14 days ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097485
Australia, Victoria | |
National Head Lice Treatment Centre | |
Ringwood East, Victoria, Australia, 3135 |
Principal Investigator: | Scott Arnold, MBBS | National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135 |
Responsible Party: | Dr. Reddy's Laboratories Limited |
ClinicalTrials.gov Identifier: | NCT02097485 |
Other Study ID Numbers: |
Ha03-008 |
First Posted: | March 27, 2014 Key Record Dates |
Results First Posted: | May 11, 2021 |
Last Update Posted: | May 11, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lice Infestations Parasitic Diseases Mite Infestations Ectoparasitic Infestations |
Skin Diseases, Parasitic Infections Skin Diseases, Infectious Skin Diseases |