Bioequivalence Study for Benzyl Alcohol Lotion 5%.

Akorn

Status and phase: Completed; Phase 3

Conditions: Head Lice

Treatments: Drug: Ulesfia (benzyl alcohol lotion) 5%; Drug: Placebo; Drug: Benzyl Alcohol Lotion 5%

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT02624843

CTHP01

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 6 months to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 3 patient groups, including a placebo group

Benzyl Alcohol Lotion 5%

Experimental group

Description:

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.

Treatment:

Drug: Benzyl Alcohol Lotion 5%

Ulesfia (Benzyl Alcohol Lotion 5%)

Active Comparator group

Description:

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.

Treatment:

Drug: Ulesfia (benzyl alcohol lotion) 5%

Vehicle Placebo Lotion 0%

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo