Bioequivalence Study for Benzyl Alcohol Lotion 5%.
Condition: Head Lice
MeSH terms: Lice Infestations
Intervention: Benzyl Alcohol Lotion 5%; Ulesfia (benzyl alcohol lotion) 5%; Placebo
Intervention description: White topical lotion; White topical lotion; White topical lotion
Intervention MeSH terms: Ethanol; Benzyl Alcohol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 239.0
Sex: All
Minimum age: 6 Months
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5%
      with Ulesfia Lotion 5% in eradication of head lice in the study subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or non-pregnant females aged 6 month or over with an upper age limit of
             60 years.

          -  Prospective participants upon examination are confirmed to have at least 3 live head
             lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs
             (nits).

          -  Prospective participants who give written informed consent or, if the participant is
             under 17 years of age, whose parent/guardian gives written informed consent to
             participate in the study.

          -  Prospective participants who will be available for follow up visits over the 21 days
             following first treatment.

          -  Prospective female participants (including female caregivers) of childbearing
             potential who are willing to provide a urine pregnancy test.

          -  Prospective participants who agree not to shave their hair or use any other
             pediculicide, nit combing, or louse treatment method during the course of the study.

        Exclusion Criteria:

          -  Prospective participants with a known sensitivity to any of the ingredients in benzyl
             alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).

          -  Prospective participants with a known history of irritation or sensitivity to
             pediculicides or hair care products.

          -  Prospective participants with a secondary bacterial infection of the scalp (eg.
             impetigo/pyoderma) or have a secondary or long term scalp condition that could make it
             difficult to evaluate the extent and severity of an infestation or that would present
             a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the
             scalp, extensive seborrheic dermatitis).

          -  Prospective participants who have been treated with other head lice products within 4
             weeks prior to randomization.

          -  Prospective participants who regularly shave their hair, have bleached their hair,
             used a permanent color on their hair, or their hair has been permanently straightened
             or waved within the previous 2 weeks.

          -  Prospective participants who have been treated with Trimethoprim containing products
             within the previous 4 weeks, or who are currently taking such a course.

          -  Females who are pregnant, planning to become pregnant, during the course of the study
             period, or are currently breast feeding mothers.

          -  Females of childbearing potential who are unwilling to use an adequate method of
             contraception from at least 4 weeks prior to the first application of treatment and
             until 4 weeks after the last application of treatment, or who are unwilling to take a
             urine pregnancy test.

          -  Prospective participants who have participated in another clinical study or used an
             investigational new drug within 1 month before entry into this study.

          -  Participants who have already participated in this clinical study.