The study will be monitored by a data safety monitoring board
(DSMB) comprised of a medical monitor, dermatologist and
statistician. The purpose of the DSMB will be to monitor the
emergence of adverse events (AEs) and serious adverse events
(SAEs) at periodic intervals throughout the enrollment and
treatment phases of the study.
ACITINIC KERATOSES
An Investigator-Initiated Study to Assess the Safety and Efficacy
of Ingenol Mebutate 0.05% Gel When Used After
Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses
(AK) on Dorsal Hands
Sequential therapy with cryosurgery and ingenol mebutate
may optimize the treatment of hypertrophic AKs and also treat
non-hypertrophic AKs in this anatomic location. Furthermore,
use of ingenol mebutate will also be evaluated for potential
treatment of subclinical lesions.
The investigators plan to treat 30 subjects. Each qualifying subject
will have at least 3 hypertrophic AKs, defined as more than
3mm in thickness, on each dorsal hand. Cryotherapy will be standardized
in all patients and for all treated lesions: 1-2 sprays, 5
seconds each, with a 5 second interval. All subjects will be treated
with the same cryo-spray. Following cryotherapy, subjects will
be randomized to treat either their right or left dorsal hand with
ingenol mebutate gel. The decision to treat the right vs. the left
hand will be chosen by chance, like flipping a coin. Neither the
subject nor the study doctor will choose what arm receives the
ingenol mebutate gel. The study doctor will not know which arm
is treated with ingenol mebutate, so the subject should not reveal
that information to him or her at any time during the study. Subjects
will treat the randomized dorsal hand with ingenol mebutate
0.05% gel starting on the same day as the cryotherapy (Day 0).
Subjects will utilize the once daily for two days regimen. Subjects
will be followed on day 4 after their initial visit, day 8, day 15, day
29, and day 57, with a two-day window period.
