NCT01068158: LICE OUT

A Double-Blind Randomized Study to Compare the Efficacy, Safety, and Local Tolerability of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation

Completed Phase 3 Results posted Last updated 4 April 2012

What this trial tests

Phase 3 trial testing 0.5% Ivermectin Cream in Head Lice in 371 participants. Completed in 1 July 2010.

Timeline

1 March 2010

Primary endpoint
1 June 2010

1 July 2010

Quick facts

Lead sponsor	Topaz Pharmaceuticals Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	371
Start date	1 March 2010
Primary completion	1 June 2010
Estimated completion	1 July 2010
Sites	7 locations across United States

Drugs / interventions tested

• 0.5% Ivermectin Cream — full drug profile →
• Placebo control

Conditions studied

• Head Lice — all drugs for Head Lice →

Sponsor

Topaz Pharmaceuticals Inc — full company profile →

Who can join

5 Months and older, 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.

• Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
  Time frame: Day 2 up to Day 15 post-application
  Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
• Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
  Time frame: Day 2 up to Day 15 post-application
  Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.

Sponsor's own description

The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Topical 0.5% ivermectin lotion for treatment of head lice.
   Pariser DM, Meinking TL, Bell M, Ryan WG. · · 2012 · cited 46× · PMID 23113480 · DOI 10.1056/nejmoa1200107