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

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.
ClinicalTrials.gov Identifier: NCT02010333
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Head Lice Infestation Drug: Ha44 Gel 0.74% w/w Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2013
Primary Completion Date : July 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ha44 Gel 0.74% w/w
Open label, one arm
Drug: Ha44 Gel 0.74% w/w


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability of Ha44 Gel [ Time Frame: 8 months ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT02010333     History of Changes
Other Study ID Numbers: Ha03-003
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015

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