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

NCT00988533 | Completed Phase 1 Results

• 1 other identifier: TOP008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Head Lice

Keywords

Head Lice; Pediculus

Outcome Measures

Primary Outcomes (4)

• Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points

  Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).

  Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application

• Summary of Pharmacokinetic Parameters Following Ivermectin Application.

  Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).

  Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application

• Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.

  Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).

  Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application

• Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.

  Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).

  Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application

Secondary Outcomes (5)

• Number of Participants Reporting Adverse Events Following Ivermectin Treatment

  Day 1 up Day 28 post-application

• Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.

  Day 2, Day 8 and Day 15 post-application

• Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.

  Day 2, Day 8 and Day 15 post-application

• Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application

  Day 1, Day 2, Day 8 and Day 15 post-application

• Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application

  Day 1, Day 2, Day 8 and Day 15 post-application

Study Arms (1)

0.5% Ivermectin Cream

EXPERIMENTAL

Drug: 0.5% Ivermectin Cream

Interventions

0.5% Ivermectin Cream DRUG

Topical 0.5% ivermectin cream applied to scalp and hair on day 1

0.5% Ivermectin Cream

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Topaz Pharmaceuticals Inc: lead

Study Sites (5)

Children's Investigational Research Program

Bentonville, Arkansas, 72712, United States

Location

Universal BioPharma Research, Inc

Dinuba, California, 93618, United States

Location

Impact Clinical Trials

Los Angeles, California, 90036, United States

Location

Lice Source Solutions Inc

Plantation, Florida, 33313, United States

Location

Spence Medical Research L.L.C

Picayune, Mississippi, 39466, United States

Location

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Topaz

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Topaz

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 25, 2012
• Results First Posted: April 25, 2012

Record last verified: 2012-03

Locations

US (5)