A Prospective Pilot Clinical Trial to Evaluate the Efficacy and Safety of Topical Therapy with Ingenol Mebutate Gel 0.015% for Actinic Keratosis on an Expanded Area of the Chest.

BACKGROUND: Ingenol mebutate gel 0.05% once daily for two consecutive days provides high clearance rates for actinic keratosis on a 25cm2 area of the chest. However, it may cause intense local skin responses. OBJECTIVE: The objective of this study was to determine whether a lower dose of ingenol mebutate gel 0.015% could clear actinic keratosis on the chest with acceptable tolerability and a possible beneficial effect on photodamage and cosmesis. DESIGN: This was a noncomparative, open-label study (NCT02446223). PARTICIPANTS: In total, 21 subjects were enrolled, and 20 completed the study. MEASUREMENTS: ingenol mebutate gel 0.015% was applied once daily for three consecutive days to a contiguous area of the chest less than 100cm2 containing four or more actinic keratoses. RESULTS: the actinic keratosis lesion count decreased by an average of 76 percent compared with baseline. signs of photoaging were reduced significantly at the end of the study, with greater than 60 percent of the subjects reporting moderate or complete satisfaction with skin improvement. Local skin responses generally resolved within two weeks of treatment. there were no adverse reactions. LIMITATIONS: this was a noncomparative, open-label study that evaluated a relatively small number of subjects. CONCLUSION: ingenol mebutate gel 0.015% applied to a less than 100cm2 area of the chest once daily for three consecutive days reduced the actinic keratosis count and significantly improved signs of photoaging with high patient satisfaction and good tolerability.