Clinical trial NCT00988533: A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Official title: An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head Lice
Keywords: Head Lice
Pediculus
Lead sponsor: Topaz Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
timeFrame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
measure: Summary of Pharmacokinetic Parameters Following Ivermectin Application.
timeFrame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
measure: Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.
timeFrame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
measure: Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.
timeFrame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Secondary outcomes:
measure: Number of Participants Reporting Adverse Events Following Ivermectin Treatment
timeFrame: Day 1 up Day 28 post-application
measure: Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
timeFrame: Day 2, Day 8 and Day 15 post-application
measure: Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.
timeFrame: Day 2, Day 8 and Day 15 post-application
measure: Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
timeFrame: Day 1, Day 2, Day 8 and Day 15 post-application
measure: Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
timeFrame: Day 1, Day 2, Day 8 and Day 15 post-application
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Children's Investigational Research Program
state: Arkansas
city: Dinuba
country: United States
facility: Universal BioPharma Research, Inc
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Plantation
country: United States
facility: Lice Source Solutions Inc
state: Florida
city: Picayune
country: United States
facility: Spence Medical Research L.L.C
state: Mississippi
Study officials:
affiliation: Sanofi Topaz
name: Medical Director
role: STUDY_DIRECTOR
References: