Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study for Benzyl Alcohol Lotion 5%.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02624843
Recruitment Status : Completed
First Posted : December 9, 2015
Results First Posted : September 3, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
South Florida Family Health and Research Centers
Axis Clinical Trials
Information provided by (Responsible Party):
Akorn, Inc.

Tracking Information
First Submitted Date  ICMJE November 25, 2015
First Posted Date  ICMJE December 9, 2015
Results First Submitted Date  ICMJE August 18, 2020
Results First Posted Date  ICMJE September 3, 2020
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE August 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study for Benzyl Alcohol Lotion 5%.
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head Lice
Intervention  ICMJE
  • Drug: Benzyl Alcohol Lotion 5%
    White topical lotion
  • Drug: Ulesfia (benzyl alcohol lotion) 5%
    White topical lotion
  • Drug: Placebo
    White topical lotion
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2020)
239
Original Actual Enrollment  ICMJE
 (submitted: December 4, 2015)
225
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624843
Other Study ID Numbers  ICMJE CTHP01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Akorn, Inc.
Study Sponsor  ICMJE Akorn, Inc.
Collaborators  ICMJE
  • South Florida Family Health and Research Centers
  • Axis Clinical Trials
Investigators  ICMJE
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
PRS Account Akorn, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP