P3 Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Accelovance Inc.
INC Research
Information provided by (Responsible Party):
Hatchtech Pty Ltd
ClinicalTrials.gov Identifier:
NCT02062060
First received: February 11, 2014
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

Purpose of this study is to evaluate the efficacy of at-home administration of a single application of abametapir lotion 0.74% w/w for the treatment of head lice.


Condition Intervention Phase
Head Lice Infestation
Drug: Abametapir Lotion 0.74% w/w
Phase 3

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: Hatchtech Study of a Randomized, Double-blind, Multicenter, Vehicle-controlled Study of the Efficacy and Safety of Abametapir Lotion 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 index subjects who are lice-free at all follow-up visits through to the Day 14 visit. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The outcome is measured by lice evaluations performed by trained lice evaluator from baseline through follow up visits.


Enrollment: 325
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abametapir Lotion 0.74% w/w
Single topical treatment administered to scalp and hair for 10 minutes. Applied at home by subject/caregiver.
Drug: Abametapir Lotion 0.74% w/w
Placebo Comparator: Vehicle Lotion
Single topical treatment administered to scalp and hair for 10 minutes. Applied at home by subject/caregiver.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, aged six months of age or older.
  2. Is in good general health based on medical history.
  3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
  4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
  5. Belongs to a household with an eligible index subject with active head lice infestation.
  6. Agrees to an examination for head lice and to all visits and procedures throughout the study.
  7. Has signed an informed consent and/or assent form.

Exclusion Criteria:

  1. Had treatment (over-the-counter), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
  2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
  3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
  4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
  5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
  6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
  7. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.
  8. Has eczema or atopic dermatitis of skin/scalp.
  9. Has had a prior reaction to Nix® or products containing permethrin.
  10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
  11. Has received an investigational agent within 30 days prior to Day 0.
  12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).
  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: NCT02062060

Locations
United States, Arizona
Cactus Kids Pediatrics
Yuma, Arizona, United States, 85364
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90017
United States, Florida
Radiant Reserach
Pinellas Park, Florida, United States, 33781
United States, Mississippi
Spence Medical Reserach
Picayune, Mississippi, United States, 39466
United States, North Carolina
Haywood Pediatric
Clyde, North Carolina, United States, 28721
United States, Tennessee
LSRN Research
Nashville, Tennessee, United States, 37206
United States, Utah
Wee Care Pediatrics
Layton, Utah, United States, 84041
Sponsors and Collaborators
Hatchtech Pty Ltd
Accelovance Inc.
INC Research
  More Information

No publications provided

Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT02062060     History of Changes
Other Study ID Numbers: Ha03-002
Study First Received: February 11, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hatchtech Pty Ltd:
Head Lice
Hatchtech

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

ClinicalTrials.gov processed this record on August 28, 2014