NCT01066585 (LICE OUT) is a Phase 3 clinical trial of Ivermectin Cream in Head Lice, sponsored by Topaz Pharmaceuticals Inc.

Who is sponsoring NCT01066585?

NCT01066585 is sponsored by Topaz Pharmaceuticals Inc.

What drugs are being tested in NCT01066585?

Interventions in NCT01066585: Ivermectin Cream, vehicle control.

Is NCT01066585 still recruiting?

NCT01066585 is currently completed. Last updated 4 April 2012.

Are results published for NCT01066585?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-04-04 · How we verify

NCT01066585: LICE OUT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 Ivermectin Cream in Head Lice in 410 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	410
Start date	1 March 2010
Primary completion	1 June 2010
Estimated completion	1 July 2010
Sites	8 locations across United States

Drugs / interventions tested

Ivermectin Cream
vehicle control — full drug profile →

Conditions studied

Head Lice — all drugs for Head Lice →

Sponsor

Topaz Pharmaceuticals Inc — full company profile →

Who can join

6 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 participants, 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.

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):

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

Verify or expand the search:

Other recruiting trials for Head Lice

Currently open trials in the same condition.

NCT07191457 — Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01066585 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Topaz Pharmaceuticals Inc
Last refreshed: 4 April 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01066585.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing