Abstract Number: 170

Evaluation of topical treatment with ingenol mebutate gel 0.015%, 3 weeks after cryosurgery of actinic keratosis on the face and scalp

N. Swanson , B. Berman , G. Goldenberg , W. Hanke , S. Tyring , W. Werschler , T. Larsson , K.M. Knudsen

Meeting: 2014 Dermcoll

Session Information

Date: -

Session Title: Poster Presentations

Session Time: -

Introduction: Although cryosurgery effectively treats individual
targeted lesions of actinic keratosis (AK), recurrence
rates are high, and the procedure fails to address the field
cancerisation of perilesional skin. We hypothesised that
sequential cryosurgery and ingenol mebutate treatment
would be superior to cryosurgery alone for both short-term
and long-term complete clearance rates. The purpose of this
study was to evaluate the short-term safety and efficacy of
sequential treatment of AKs on the face or scalp with cryosurgery
followed by treatment with ingenol mebutate gel
0.015%, compared with cryosurgery followed by vehicle gel.
Methods: This is the 11-week analysis of a Phase III,
randomised, double-blind, vehicle-controlled 12-month
study (NCT01541553). Patients received liquid nitrogen
cryosurgery to all visible AKs and, after a 3-week healing
period, once-daily treatment with either ingenol mebutate
gel 0.015% or vehicle gel for 3 consecutive days. Patients
had 4–8 clinically typical and discrete AKs within a contiguous
25-cm treatment area on the face or scalp. The primary
efficacy endpoint was the rate of complete clearance of AKs,
defined as no clinically visible AKs in the selected treatment
area, at Week 11. Safety assessments included all adverse
events (AEs) and the incidence and severity of local skin
reactions (LSRs).
Results: A total of 329 randomized patients were treated
with ingenol mebutate gel (n = 167) or vehicle gel (n = 162)
after cryosurgery. The percentage of patients who achieved
complete clearance was significantly higher in the ingenol
mebutate group than in the vehicle group (60.5% vs 49.4%)
(P = 0.04). Complete clearance rates by anatomic location
were also higher with ingenol mebutate than with vehicle:
face, 59.5% vs 47.8%; scalp, 63.9% vs 57.1%. The most
common AE related to ingenol mebutate gel treatment was
application-site pain, occurring in 7 (4.2%) patients. LSRs
from treatment with 0.015% ingenol mebutate gel were of
similar magnitude to those in the Phase III trials, peaking
within a few days after treatment completion, returning to
near baseline 2 weeks after treatment.
Conclusions: The short-term rate of complete clearance of
AK on the face or scalp was improved after sequential
topical treatment with ingenol mebutate gel 0.015% following
cryosurgery. Although cryosurgery was effective at
reducing AK, the short-term clearance rate of AKs was significantly
higher when cryosurgery was followed by topical
treatment with ingenol mebutate than when it was followed
by vehicle gel. No safety concerns were identified, and
topical treatment after cryosurgery produced LSRs comparable
to those previously reported.
Funding: LEO Pharma.