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Safety and PK Study of Ha44 Gel Under Maximal Use Conditions 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. Identifier: NCT01907490
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : February 9, 2015
Last Update Posted : April 26, 2017
Target Health Inc.
Information provided by (Responsible Party):
Hatchtech Pty Ltd

Brief Summary:

The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.

Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.

Condition or disease Intervention/treatment Phase
Head Lice Infestation Drug: Ha44 Gel Phase 2

Detailed Description:

This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.

All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.

Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.

More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes
Drug: Ha44 Gel
Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
Other Name: Benzyl Alcohol

Primary Outcome Measures :
  1. Number of the Subjects With AEs. [ Time Frame: 3 months ]
    Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.

Secondary Outcome Measures :
  1. Pk Parameters: Cmax [ Time Frame: 3 months ]
    Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation

  2. PK Parameters: Tmax [ Time Frame: 3 months ]
    Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation

  3. PK Parameters: AUC [ Time Frame: 3 months ]
    Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female
  2. 6 months to 17 years of age
  3. Be in good health, as determined by medical history and physical examination
  4. Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.
  5. 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. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months.
  6. The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
  7. Has signed an informed consent and/or assent form (ICF).

Exclusion Criteria:

  1. Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
  2. Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
  3. Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
  4. Has been using hormonal contraception for less than 3 months.
  5. Is pregnant or currently nursing.
  6. Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
  7. Has received an investigational agent within 30 days prior to Day 0.

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Responsible Party: Hatchtech Pty Ltd Identifier: NCT01907490     History of Changes
Other Study ID Numbers: Ha03-004
First Posted: July 25, 2013    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: April 26, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hatchtech Pty Ltd:
Topical treatment of Head Lice Infestation

Additional relevant MeSH terms:
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Lice Infestations
Parasitic Diseases
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Benzyl Alcohol
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents