Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Cryotherapy followed by PEP005 Gel, 0.015%

Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area

Cryotherapy

Field treatment with vehicle gel once daily for 3 consecutive days.

Vehicle

Ingenol metabute

Brian Berman, MD, Ph.D

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.

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

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.

Percentage change from baseline in number of AKs at Week 11

Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11

LEO Pharma

Cryotherapy followed by PEP005 Gel, 0.015%

Cryotherapy of all visible AKs (4-8 lesions, "baseline AKs") in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days

PEP005 Gel, 0.015%

Cryotherapy followed by vehicle gel

Cryotherapy of all visible AKs (4-8 lesions, "baseline AKs") in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days.

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