- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01907490
Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female
- 6 months to 17 years of age
- Be in good health, as determined by medical history and physical examination
- 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.
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.
- The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
- Has signed an informed consent and/or assent form (ICF).
Exclusion Criteria:
- Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
- 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.
- Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- Has been using hormonal contraception for less than 3 months.
- Is pregnant or currently nursing.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of the Subjects With AEs.
Time Frame: 3 months
|
Safety and tolerability assessed by AEs.
Number of subjects with reporting AEs.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pk Parameters: Cmax
Time Frame: 0 to 8 hours
|
Maximum concentration of Ha44 (Cmax)
|
0 to 8 hours
|
PK Parameters: Tmax
Time Frame: 0-8 hours
|
Time to maximum concentration of Ha44 (Tmax)
|
0-8 hours
|
PK Parameters: AUC(0-8)
Time Frame: 0-8 hours
|
Area under the concentration-time curve of Ha44 (AUC 0-8)
|
0-8 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Ectoparasitic Infestations
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Lice Infestations
- Parasitic Diseases
- Mite Infestations
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Benzyl Alcohol
Other Study ID Numbers
- Ha03-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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