Phase 3
N=239
Bioequivalence Study for Benzyl Alcohol Lotion 5%.
Head Lice
Bottom Line
View on ClinicalTrials.gov: NCT02624843 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Infestation Successfully Eliminated by Active Treatment. — 59; 57; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Benzyl Alcohol Lotion 5% (Drug); Ulesfia (benzyl alcohol lotion) 5% (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Akorn, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Infestation Successfully Eliminated by Active Treatment. |
59; 57; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02624843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.