NCT00988533

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

Completed Phase 1 Results posted Last updated 30 March 2012

What this trial tests

Phase 1 trial testing 0.5% Ivermectin Cream in Head Lice in 30 participants. Completed in 1 November 2009.

Timeline

1 September 2009

Primary endpoint
1 November 2009

1 November 2009

Quick facts

Lead sponsor	Topaz Pharmaceuticals Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 September 2009
Primary completion	1 November 2009
Estimated completion	1 November 2009
Sites	5 locations across United States

Drugs / interventions tested

• 0.5% Ivermectin Cream — full drug profile →

Conditions studied

• Head Lice — all drugs for Head Lice →

Sponsor

Topaz Pharmaceuticals Inc — full company profile →

Who can join

Adults 6 Months to 3, any sex, with Head Lice. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
  Time frame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
  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).
• Summary of Pharmacokinetic Parameters Following Ivermectin Application.
  Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-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).
• Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.
  Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-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).
• Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.
  Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-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).

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.