Bioequivalence Study for Benzyl Alcohol Lotion 5%.

NCT ID: NCT02624843

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

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.

Conditions

Head Lice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Benzyl Alcohol Lotion 5%

Intervention Type: DRUG

White topical lotion

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.

Group Type: ACTIVE_COMPARATOR

Ulesfia (benzyl alcohol lotion) 5%

Intervention Type: DRUG

White topical lotion

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

White topical lotion

Interventions

Benzyl Alcohol Lotion 5%

White topical lotion

Intervention Type: DRUG

Ulesfia (benzyl alcohol lotion) 5%

White topical lotion

Intervention Type: DRUG

Placebo

White topical lotion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Florida Family Health and Research Centers

NETWORK

Sponsor Role: collaborator

Axis Clinical Trials

OTHER

Sponsor Role: collaborator

Akorn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Rivera

Role: PRINCIPAL_INVESTIGATOR

South Florida Family Health and Research Centers

Lydie Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

Axis Clinical Trials

Patrick Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Axis Clinical Trials

Lidia E Serrano

Role: PRINCIPAL_INVESTIGATOR

South Florida Family Health and Research Centers

Nancy Pyram-Bernard, D.O.

Role: PRINCIPAL_INVESTIGATOR

South Florida Family Health and Research Centers

Ian F Burgess, M.Phil.

Role: STUDY_DIRECTOR

Insect Research and Development LTD

Locations

Axis Clinical Trials

Los Angeles, California, United States

Axis Clinical Trials

Los Angeles, California, United States

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

Miami, Florida, United States

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

Plantation, Florida, United States

Countries

United States

Other Identifiers

CTHP01

Identifier Type: -

Identifier Source: org_study_id