Clinical Trial: Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.

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.


Detailed Summary:

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.


Sponsor: Hatchtech Pty Ltd

Current Primary Outcome: Number of the Subjects With AEs. [ Time Frame: 3 months ]

Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.


Original Primary Outcome: Evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/v [ Time Frame: 3 months ]

Safety and tolerability assessed by following measures: AEs, Clinical Laboratory Tests, Vital Signs, Physical examination and scalp and skin assessments.


Current Secondary Outcome:

  • Pk Parameters: Cmax [ Time Frame: 3 months ]
    Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
  • PK Parameters: Tmax [ Time Frame: 3 months ]
    Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
  • PK Parameters: AUC [ Time Frame: 3 months ]
    Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation


Original Secondary Outcome: Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation [ Time Frame: 3 months ]

Pk parameters: C-max, T-max and AUC (0-8)


Information By: Hatchtech Pty Ltd

Dates:
Date Received: July 22, 2013
Date Started: March 2013
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017