Bioequivalence Study for Benzyl Alcohol Lotion 5%. (NCT02624843) | Clinical Trial Compass
CompletedPhase 3
Bioequivalence Study for Benzyl Alcohol Lotion 5%.
United States239 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range6 Months – 60 Years
SexALL
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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 respons…
What they're measuring
1
Number of Participants With Infestation Successfully Eliminated by Active Treatment.