Clinical trial NCT02624843: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head Lice
Lead sponsor: Akorn, Inc.
Sponsor class: INDUSTRY
Collaborators: name: South Florida Family Health and Research Centers
name: Axis Clinical Trials
First posted: 2015-12-09
Enrollment: 239
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Infestation Successfully Eliminated by Active Treatment.
timeFrame: Study Day 22 +/-2
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Miami
country: United States
facility: South Florida Family Health and Research Centers (Lice Source Services Inc)
state: Florida
city: Plantation
country: United States
facility: South Florida Family Health and Research Centers (Lice Source Services Inc)
state: Florida
Study officials:
affiliation: South Florida Family Health and Research Centers
name: Elisabeth Rivera
role: PRINCIPAL_INVESTIGATOR
affiliation: Axis Clinical Trials
name: Lydie Hazan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Axis Clinical Trials
name: Patrick Clarke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Florida Family Health and Research Centers
name: Lidia E Serrano
role: PRINCIPAL_INVESTIGATOR
affiliation: South Florida Family Health and Research Centers
name: Nancy Pyram-Bernard, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Insect Research and Development LTD
name: Ian F Burgess, M.Phil.
role: STUDY_DIRECTOR
References: