An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

Study Overview
=================
Brief Summary
-----------------
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice

Official Title
-----------------
An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

Conditions
-----------------
Pediculosis

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* Low Dose Ha44 Gel applied to scalp and hair for 10 minutes<br>|
| Experimental: Group B<br>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<br>* High Dose Ha44 Gel applied to scalp and hair for 10 minutes<br>|
| Placebo Comparator: Group C<br>Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration. | Drug: Group C - Placebo<br>* Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit |  | Follow up visit at days 1, 7 and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Ha44 Gel | The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group. | From treatment to last visit of the study at 14 days |