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

Objectives: 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. Design: Investigatorblinded split arm study. Setting: Academic institution. Participants: 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. Conclusion: 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. Trial registry: ClinicalTrials.gov, NCT02251652.