A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hatchtech Pty Ltd
ClinicalTrials.gov Identifier:
NCT02010333
First received: December 9, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.


Condition Intervention Phase
Head Lice Infestation
Drug: Ha44 Gel 0.74% w/w
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hatchtech Pty Ltd:

Primary Outcome Measures:
  • Safety and tolerability of Ha44 Gel [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.


Estimated Enrollment: 22
Study Start Date: April 2013
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ha44 Gel 0.74% w/w
Open label, one arm
Drug: Ha44 Gel 0.74% w/w

  Eligibility

Ages Eligible for Study:   6 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 6months < 3years of age
  2. Good health
  3. Active head lice infestation defined as the presence of at least 3 live lice
  4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
  5. Parent/guardian agrees to allow PK samples collected
  6. Signed Informed Consent Form

Exclusion Criteria:

  1. Condition or illness that in the opinion of the investigator may interfere with the study results.
  2. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
  3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
  4. Receiving systemic or topical medication that may interfere the study results.
  5. 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: NCT02010333

Locations
United States, California
Universal Biopharma Research Institute
Dinuba, California, United States, 93618
Axis Clinical Trials
Los Angeles, California, United States, 90036
Sponsors and Collaborators
Hatchtech Pty Ltd
  More Information

No publications provided

Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT02010333     History of Changes
Other Study ID Numbers: Ha03-003
Study First Received: December 9, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014