Bioequivalence Study for Benzyl Alcohol Lotion 5%.

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.

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.

Study Overview

• Status: Completed
• Conditions: Head Lice
• Intervention / Treatment: Drug: Benzyl Alcohol Lotion 5%; Drug: Ulesfia (benzyl alcohol lotion) 5%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Los Angeles, California, United States, 90017
      • Axis Clinical Trials
  • Florida
    • Miami, Florida, United States, 33186
      • South Florida Family Health and Research Centers (Lice Source Services Inc)
    • Plantation, Florida, United States, 33313
      • South Florida Family Health and Research Centers (Lice Source Services Inc)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Benzyl Alcohol Lotion 5%; White topical lotion
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.	Drug: Ulesfia (benzyl alcohol lotion) 5%; White topical lotion
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.	Drug: Placebo; White topical lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Infestation Successfully Eliminated by Active Treatment.	Successful elimination of infestation by active treatment [Time frame: 22 + 2 days]. No evidence of active head lice infestation 22 days after enrollment.	Study Day 22 +/-2

Collaborators and Investigators

• Sponsor: Akorn, Inc.
• Collaborators: South Florida Family Health and Research Centers; Axis Clinical Trials
• Investigators: Principal Investigator: Elisabeth Rivera, South Florida Family Health and Research Centers; Principal Investigator: Lydie Hazan, MD, Axis Clinical Trials; Principal Investigator: Patrick Clarke, MD, Axis Clinical Trials; Principal Investigator: Lidia E Serrano, South Florida Family Health and Research Centers; Principal Investigator: Nancy Pyram-Bernard, D.O., South Florida Family Health and Research Centers; Study Director: Ian F Burgess, M.Phil., Insect Research and Development LTD

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ethanol; Benzyl Alcohol
• Other Study ID Numbers: CTHP01