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Bioequivalence Study for Benzyl Alcohol Lotion 5%.

Primary Purpose

Head Lice

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Benzyl Alcohol Lotion 5%

Ulesfia (benzyl alcohol lotion) 5%

Placebo

About this trial

This is an interventional treatment trial for Head Lice

Eligibility Criteria

6 Months - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Axis Clinical Trials
Axis Clinical Trials
South Florida Family Health and Research Centers (Lice Source Services Inc)
South Florida Family Health and Research Centers (Lice Source Services Inc)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Benzyl Alcohol Lotion 5%

Ulesfia (Benzyl Alcohol Lotion 5%)

Vehicle Placebo Lotion 0%

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02624843

First Posted

November 25, 2015

Last Updated

January 11, 2021

Sponsor

Akorn, Inc.

Collaborators

South Florida Family Health and Research Centers, Axis Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT02624843

Brief Title

Bioequivalence Study for Benzyl Alcohol Lotion 5%.

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 Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akorn, Inc.

Collaborators

South Florida Family Health and Research Centers, Axis Clinical Trials

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Lice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benzyl Alcohol Lotion 5%

Arm Type

Experimental

Arm Description

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.

Arm Title

Ulesfia (Benzyl Alcohol Lotion 5%)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Vehicle Placebo Lotion 0%

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Benzyl Alcohol Lotion 5%

Intervention Description

White topical lotion

Intervention Type

Drug

Intervention Name(s)

Ulesfia (benzyl alcohol lotion) 5%

Intervention Description

White topical lotion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

White topical lotion

Primary Outcome Measure Information:

Title

Number of Participants With Infestation Successfully Eliminated by Active Treatment.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: