Efficacy and Safety of Ingenol Mebutate 0.015% Gel 3 Weeks After Cryosurgery of Actinic Keratosis: 11-Week Results
February 2014 | Volume 13 | Issue 2 | Original Article | 154 | Copyright © February 2014
Brian Berman MD PhD,a Gary Goldenberg MD,b C. William Hanke MD,c Stephen K. Tyring MD PhD,d Wm Philip Werschler MD,e Kim Mark Knudsen PhD,f Joana Goncalves MD,g Thomas Larsson Dr Med Sci,h Torsten Skov MD PhD,i and Neil Swanson MDj
aDepartment of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL
bDepartment of Dermatology, Mount Sinai School of Medicine, New York, NY
cDermatologic Surgery, Laser and Skin Surgery Center of Indiana, Carmel, IN
dDepartments of Microbiology and Immunology, Dermatology and Internal Medicine, University of Texas Health Science Center, Houston, TX
eDepartment of Medicine/Dermatology, University of Washington School of Medicine, Seattle, WA
fBiostatistics and Data Management, LEO Pharma A/S, Ballerup, Denmark
gLEO Pharma Inc, Parsippany, NJ
hCentre of Excellence Scientific Affairs, LEO Pharma A/S, Ballerup, Denmark
iMedical Department, LEO Pharma A/S, Ballerup, Denmark
jDepartment of Dermatology, Oregon Health and Science University, Portland, OR
METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle.
RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated.
CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.
J Drugs Dermatol. 2014;13(2):154-160.