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CompletedNCT02624843Updated Jan 27, 2021Results posted

Bioequivalence Study for Benzyl Alcohol Lotion 5%.

A Phase 3 interventional study of Benzyl Alcohol Lotion 5% and Ulesfia (benzyl alcohol lotion) 5% in Head Lice, sponsored by Akorn, Inc.. Completed at 4 sites in United States. Open to participants aged 6 Months to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Akorn, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
239
Allocation
Randomized
Ages
6 Months to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Head Lice

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03

Who can participate

Ages eligible
6 Months to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
239 participants (actual)

Study arms

  • 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%

  • 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%

  • 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

Interventions

  • DrugBenzyl Alcohol Lotion 5%

    White topical lotion

  • DrugUlesfia (benzyl alcohol lotion) 5%

    White topical lotion

  • DrugPlacebo

    White topical lotion

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Study Day 22 +/-2

06

Results

Posted Sep 3, 2020

Participant flow

Participant flow — Overall Study
MilestoneBenzyl Alcohol Lotion 5%Ulesfia (Benzyl Alcohol Lotion 5%)Vehicle Placebo Lotion 0%
Started10710824
Completed707216
Not completed37368

Outcome measures

PrimaryNumber 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.

Time frame:
Study Day 22 +/-2
Reported as:
Count of participants · Participants
Number of Participants With Infestation Successfully Eliminated by Active Treatment.
ParticipantsBenzyl Alcohol Lotion 5%Ulesfia (Benzyl Alcohol Lotion 5%)Vehicle Placebo Lotion 0%
Number of Participants With Infestation Successfully Eliminated by Active Treatment.59576

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Benzyl Alcohol Lotion 5%0/107 (0%)0/107 (0%)2/107 (1.9%)
Ulesfia (Benzyl Alcohol Lotion 5%)0/108 (0%)0/108 (0%)1/108 (0.9%)
Vehicle Placebo Lotion 0%0/24 (0%)0/24 (0%)0/24 (0%)
Most frequent other events
Most frequent other events
EventBenzyl Alcohol Lotion 5%Ulesfia (Benzyl Alcohol Lotion 5%)Vehicle Placebo Lotion 0%
Skin, nervous system and general disorderSkin and subcutaneous tissue disorders1/1070/1080/24
redness of eyeEye disorders1/1070/1080/24
feverGeneral disorders0/1071/1080/24

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Benzyl Alcohol Lotion 5%Ulesfia (Benzyl Alcohol Lotion 5%)Vehicle Placebo Lotion 0%Total
<=18 years778518180
Between 18 and 65 years3023659
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Benzyl Alcohol Lotion 5%Ulesfia (Benzyl Alcohol Lotion 5%)Vehicle Placebo Lotion 0%Total
Female1029824224
Male510015
Region of Enrollment
Region of Enrollment(participants)Benzyl Alcohol Lotion 5%Ulesfia (Benzyl Alcohol Lotion 5%)Vehicle Placebo Lotion 0%Total
United States10710824239
07

Study locations

4 sites
  • Axis Clinical Trials
    Los Angeles, California 90017, United States
  • Axis Clinical Trials
    Los Angeles, California 90036, United States
  • South Florida Family Health and Research Centers (Lice Source Services Inc)
    Miami, Florida 33186, United States
  • South Florida Family Health and Research Centers (Lice Source Services Inc)
    Plantation, Florida 33313, United States
08

Registry details

Key details

Study ID
NCT02624843
Lead sponsor
Akorn, Inc.
Collaborators
South Florida Family Health and Research Centers, Axis Clinical Trials
Responsible party
Sponsor
First posted
Dec 9, 2015
Start date
Aug 2015
Primary completion
Nov 2015
Completion
Nov 2015
Results posted
Sep 3, 2020
Last update
Jan 27, 2021

Study contacts

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

Oversight

Data monitoring committee
No
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