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

Phase 2

Completed

Interventions: 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

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group A	Group A - Low-Dose Ha44 0.37% w/w	Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes.
Group B	Group B - High Dose Ha44 Gel 0.74% w/w	Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration.
Group C	Group C - Placebo	Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.

Primary Outcome Measures

Name	Time	Method
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

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

Locations (2): Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
Universal BioPharma Research Institute, Inc.
🇺🇸
Dinuba, California, United States