An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Condition: Pediculosis
MeSH terms: Lice Infestations
Intervention: Group A - Low-Dose Ha44 0.37% w/w; Group B - High Dose Ha44 Gel 0.74% w/w; Group C - Placebo
Intervention description: Low Dose Ha44 Gel applied to scalp and hair for 10 minutes; High Dose Ha44 Gel applied to scalp and hair for 10 minutes; Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

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

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