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

Abstract

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: Investigator-blinded 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.

Figures

Figure 1.

Localized skin reactions for participants receiving cryosurgery alone

Figure 2.

Localized skin reactions for participants receiving cryosurgery with ingenol mebutate 0.05%