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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
Last Update Posted : December 9, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Head Lice Drug: Benzyl Alcohol Lotion 5% Drug: Ulesfia (benzyl alcohol lotion) 5% Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : August 2015
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lice
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624843


Locations
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90017
Axis Clinical Trials
Los Angeles, California, United States, 90036
United States, Florida
South Florida Family Health and Research Centers (Lice Source Services Inc)
Miami, Florida, United States, 33186
South Florida Family Health and Research Centers (Lice Source Services Inc)
Plantation, Florida, United States, 33313
Sponsors and Collaborators
Akorn, Inc.
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
More Information

Responsible Party: Akorn, Inc.
ClinicalTrials.gov Identifier: NCT02624843     History of Changes
Other Study ID Numbers: CTHP01
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Ethanol
Benzyl Alcohol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents