Bioequivalence Study for Benzyl Alcohol Lotion 5%.

Overview

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.

Full Title of Study: “Bioequivalence Study for Benzyl Alcohol Lotion 5% (Hi-Tech Pharmacal Co. LTD) and Ulesfia (Benzyl Alcohol Lotion 5%) (Shionogi Inc.) in the Treatment of Head Lice and Their Ova.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2015

Interventions

  • Drug: Benzyl Alcohol Lotion 5%
    • White topical lotion
  • Drug: Ulesfia (benzyl alcohol lotion) 5%
    • White topical lotion
  • Drug: Placebo
    • White topical lotion

Arms, Groups and Cohorts

  • Experimental: Benzyl Alcohol Lotion 5%
    • Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
  • Active Comparator: Ulesfia (Benzyl Alcohol Lotion 5%)
    • Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
  • Placebo Comparator: Vehicle Placebo Lotion 0%
    • Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with infestation successfully eliminated by active treatment.
    • Time Frame: Study Day 22 +/-2
    • Successful elimination of infestation by active treatment [Time frame: 22 + 2 days]. No evidence of active head lice infestation 22 days after enrollment.

Secondary Measures

  • Failure to eliminate infestation by placebo treatment.
    • Time Frame: Study Day 22 +/-2
    • Failure to eliminate infestation by placebo treatment [Time frame 22 + 2 days]. Head lice present during 22 days after enrollment.
  • Number of participants with treatment related adverse events as a measure of safety.
    • Time Frame: Study Day 22 +/-2
    • Number of participants with treatment related adverse events as a measure of safety.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Akorn, Inc.
  • Collaborator
    • South Florida Family Health and Research Centers
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elisabeth Rivera, Principal Investigator, South Florida Family Health and Research Centers
    • Lydie Hazan, MD, Principal Investigator, Axis Clinical Trials
    • Patrick Clarke, MD, Principal Investigator, Axis Clinical Trials
    • Lidia E Serrano, Principal Investigator, South Florida Family Health and Research Centers
    • Nancy Pyram-Bernard, D.O., Principal Investigator, South Florida Family Health and Research Centers
    • Ian F Burgess, M.Phil., Study Director, Insect Research and Development LTD

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