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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:
ClinicalTrials.gov Identifier:
NCT01336647
First Posted: April 18, 2011
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hatchtech Pty Ltd
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Safety and Tolerability of Ha44 Gel [ Time Frame: From treatment to last visit of the study at 14 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 14, 2011
First Posted: April 18, 2011
Results First Submitted: December 4, 2013
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015
Last Verified: January 2015

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