An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hatchtech Pty Ltd
ClinicalTrials.gov Identifier:
NCT01336647
First received: April 14, 2011
Last updated: September 4, 2011
Last verified: September 2011
  Purpose

Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice


Condition Intervention Phase
Pediculosis
Drug: Ha44 Gel
Drug: Placebo
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: An Efficacy and Safety Study of Ha44 Gel Administered Topically 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 all subjects who are lice free at all follow-up visits through the Day 14 visit [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of Ha44 Gel [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

    The number and percentage of subjects with Treatment emergent AEs (TEAEs) will be reported by treatment group including relationship to study medication.

    Changes from baseline of Clinical Laboratory results will be summarized across treatment groups. Vital signs, ECG, physical exam findings, and scalp/eye irritation assessment data will be summarized by treatment group. Changes from baseline in these parameters will be summarized across treatment groups at each applicable post-randomization visit.



Enrollment: 142
Study Start Date: April 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Low-Dose Ha44
Drug: Ha44 Gel
Low Dose Ha44
Experimental: Group B
High-Dose Ha44
Drug: Ha44 Gel
High Dose Ha44
Placebo Comparator: Group C
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 years of age or older
  • Body weight of at least 33 pounds
  • Has an active head lice infestation at Day 0. An active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members
  • Belong to a household of no more than 6 members, except where additional household members are < 2 years of age
  • Belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation
  • Female subjects must be:

    • of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or, post-menopausal for at least 2 years) OR,
    • if of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit.

Exclusion Criteria:

  • Had treatment for head lice within 14 days prior to Day 0
  • Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment
  • Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results
  • Has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment
  • Has been using hormonal contraception for less than 3 months or is pregnant or lactating
  • Has received systemic corticosteroids within 7 days prior to Day 0 or planned while on study
  • Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results
  • Has received an investigational agent within 30 days prior to Day 0
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336647

Locations
United States, California
Universal BioPharma Research Institute, Inc.
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: NCT01336647     History of Changes
Other Study ID Numbers: Ha02-003
Study First Received: April 14, 2011
Last Updated: September 4, 2011
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 April 22, 2014