An Investigator-initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryosurgery in the Treatment of Hypertrophic Actinic Keratosis on Dorsal Hands.
OBJECTIVE
To evaluate the safety and efficacy of ingenol mebutate 0.05% gel after cryosurgery versus cryosurgery alone for the treatment of hypertrophic and nonhypertrophic actinic keratosis on the dorsal hands.


METHODS
Investigator-blinded split arm study.


METHODS
Academic institution.


METHODS
Sixteen subjects with actinic keratoses on dorsal hands.


RESULTS
There was a mean reduction in the number of hypertrophic actinic keratosis lesions adjusted for baseline in ingenol mebutate-treated versus control group of -4.3 versus -2.8, respectively. There was a mean reduction in the number of non-hypertrophic actinic keratosis lesions in the ingenol mebutate-treated versus control group of -3.8 versus -0.3.


CONCLUSIONS
A statistically significant and clinically meaningful difference in response was demonstrated in favor of ingenol mebutate-treated hands versus controls. No significant increase in local skin responses was noted when applying ingenol mebutate 0.05% gel on the same day as cryosurgery.


BACKGROUND
ClinicalTrials.gov, NCT02251652.
The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
Peter W
PW
Hashim
The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
John K
JK
Nia
The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
Skylar
S
Singer
The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
Gary
G
Goldenberg
Actas Dermosifiliogr. 2015 Dec;106(10):e55-61
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