Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
Condition: Head Lice Infestation
MeSH terms: Lice Infestations; Parasitic Diseases; Mite Infestations
Intervention: Ha44 Gel
Intervention description: 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.
Intervention MeSH terms: Benzyl Alcohol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Topical treatment of Head Lice Infestation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female

          2. 6 months to 17 years of age

          3. Be in good health, as determined by medical history and physical examination

          4. 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.

          5. 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.

          6. The parent/guardian agrees to allow serial blood samples collected from subject for PK
             analysis during study.

          7. Has signed an informed consent and/or assent form (ICF).

        Exclusion Criteria:

          1. Has a condition or illness that, in the opinion of the Investigator, may interfere
             with the study results.

          2. 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.

          3. Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or
             pyrethrum extract.

          4. Has been using hormonal contraception for less than 3 months.

          5. Is pregnant or currently nursing.

          6. Receiving systemic or topical medication, which in the opinion of the Investigator,
             may interfere with the study results.

          7. Has received an investigational agent within 30 days prior to Day 0.