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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: January 13, 2015
Last verified: January 2015
  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: Group A - Low-Dose Ha44 0.37% w/w
Drug: Group B - High Dose Ha44 Gel 0.74% w/w
Drug: Group C - 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:
  • Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit [ Time Frame: Follow up visit at days 1, 7 and 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability of Ha44 Gel [ Time Frame: From treatment to last visit of the study at 14 days ] [ Designated as safety issue: Yes ]
    The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.


Enrollment: 142
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
Drug: Group A - Low-Dose Ha44 0.37% w/w
Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
Experimental: Group B
Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.
Drug: Group B - High Dose Ha44 Gel 0.74% w/w
High Dose Ha44 Gel applied to scalp and hair for 10 minutes
Placebo Comparator: Group C
Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
Drug: Group C - Placebo
Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

  Eligibility

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
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
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: 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
Investigators
Principal Investigator: Miguel Restrepo Universal Biopharma Reserach Inc.
Principal Investigator: Lydie Hazan Axis Clinical Trials
  More Information

Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT01336647     History of Changes
Other Study ID Numbers: Ha02-003 
Study First Received: April 14, 2011
Results First Received: December 4, 2013
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 08, 2016