Bioequivalence Study for Benzyl Alcohol Lotion 5%.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Head Lice

Intervention / Treatment
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* Drug: Benzyl Alcohol Lotion 5%
* Drug: Ulesfia (benzyl alcohol lotion) 5%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benzyl Alcohol Lotion 5%<br>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%<br>* White topical lotion<br>|
| Active Comparator: Ulesfia (Benzyl Alcohol Lotion 5%)<br>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%<br>* White topical lotion<br>|
| Placebo Comparator: Vehicle Placebo Lotion 0%<br>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<br>* White topical lotion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |