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

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ClinicalTrials.gov Identifier: NCT02097485
Recruitment Status : Completed
First Posted : March 27, 2014
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head Lice Infestation Drug: Abametapir Lotion 0.74% w/w Drug: Vehicle Lotion Phase 2

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.
Study Design
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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

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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


Locations
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Australia, Victoria
National Head Lice Treatment Centre
Ringwood East, Victoria, Australia, 3135
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Scott Arnold, MBBS National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lice Infestations
Parasitic Diseases
Mite Infestations
Ectoparasitic Infestations
 Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases