Bioequivalence Study for Benzyl Alcohol Lotion 5%.

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akorn, Inc.
• Collaborators: Axis Clinical Trials; South Florida Family Health and Research Centers
• Treatments: Benzyl Alcohol; Ethanol

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.