Bioequivalence Study for Benzyl Alcohol Lotion 5%.

NCT02624843 | Completed Phase 3 Results

• 1 other identifier: CTHP01
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 4

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

Outcome Measures

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.

  Study Day 22 +/-2

Study Arms (3)

Benzyl Alcohol Lotion 5%

EXPERIMENTAL

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%

Ulesfia (Benzyl Alcohol Lotion 5%)

ACTIVE COMPARATOR

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%

Vehicle Placebo Lotion 0%

PLACEBO COMPARATOR

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

Benzyl Alcohol Lotion 5% DRUG

White topical lotion

Benzyl Alcohol Lotion 5%

Ulesfia (benzyl alcohol lotion) 5% DRUG

White topical lotion

Ulesfia (Benzyl Alcohol Lotion 5%)

Placebo DRUG

White topical lotion

Vehicle Placebo Lotion 0%

Eligibility Criteria

• Age: 6 Months - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akorn, Inc.: lead
• South Florida Family Health and Research Centers: collaborator
• Axis Clinical Trials: collaborator

Study Sites (4)

Axis Clinical Trials

Los Angeles, California, 90017, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

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

Miami, Florida, 33186, United States

Location

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

Plantation, Florida, 33313, United States

Location

MeSH Terms

Interventions

Ethanol; Benzyl Alcohols

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Elisabeth Rivera
• Organization: South Florida Family Health & Research

elisabeth@sffhrc.com

3053870051

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Ian F Burgess, M.Phil.

  Insect Research and Development LTD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 9, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 27, 2021
• Results First Posted: September 3, 2020

Record last verified: 2021-01

Locations

US (4)