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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hatchtech Pty Ltd
Sponsor:
Information provided by (Responsible Party):
Hatchtech Pty Ltd
ClinicalTrials.gov Identifier:
NCT02097485
First received: March 24, 2014
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The purpose of the study is to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hatchtech Pty Ltd:

Primary Outcome Measures:
  • Proportion of hatched eggs pre treatment relative to proportion of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097485

Contacts
Contact: Scott Arnold, MBBS irondoc@bigpond.com

Locations
Australia, Victoria
National Head Lice Treatment Centre Recruiting
Ringwood East, Victoria, Australia, 3135
Contact: Scott Arnold       irondoc@bigpond.com   
Principal Investigator: Scott Arnold         
Sponsors and Collaborators
Hatchtech Pty Ltd
  More Information

No publications provided

Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT02097485     History of Changes
Other Study ID Numbers: Ha03-008
Study First Received: March 24, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Parasitic Diseases
Mite Infestations
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014