A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

Topaz Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Head Lice

Treatments

Drug: 0.5% Ivermectin Cream

Study type

Interventional

Funder types

Industry

Identifiers

TOP008

Details and patient eligibility

About

The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.

Enrollment

30 patients

Sex

All

Ages

6 months to 3 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.
Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.
Subject is in general good health.
Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.
Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).
Subject's caregiver must agree to comply with the following study restrictions:
- will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel.
- will not shampoo, wash, or rinse the subject's hair or scalp until the Day 2 treatment evaluation has been completed.
- will not cut or chemically treat subject's hair in the period between screening and follow-up on Day 15.
- will use only study-provided shampoo on the subject for the duration of the study.
- will follow all study instructions.

Exclusion criteria

Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.
Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.
Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.
Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.
Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is > 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.
Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation.
Subjects who have been treated with a systemic antibiotic within 2 weeks before screening.
Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening.
Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.