Who is sponsoring NCT01541553?

NCT01541553 is sponsored by LEO Pharma.

What condition does NCT01541553 study?

NCT01541553 studies Actinic Keratosis.

What drugs are being tested in NCT01541553?

Interventions: Cryotherapy, Vehicle, Ingenol metabute.

What is the status of NCT01541553?

NCT01541553 is currently COMPLETED.

Last reviewed 2025-02-21 · How we verify

A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

NCT01541553 Phase 3 COMPLETED Results posted

The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Details

Lead sponsor	LEO Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	367
Start date	2012-03
Completion	2013-07

Conditions

Actinic Keratosis

Interventions

Cryotherapy
Vehicle
Ingenol metabute

Primary outcomes

Complete Clearance of AKs at Week 11 — 11 weeks
To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Countries

United States