Clinical and Histologic Evaluation of Ingenol Mebutate 0.015% Gel for the Cosmetic Improvement of Photoaged Skin.

BACKGROUND No studies have examined the use of topical ingenol mebutate for improvement of photoaged skin. OBJECTIVE To evaluate clinical results of ingenol mebutate gel applied to photoaged skin and to quantify improvement at 7, 30, and 60 days after application. MATERIALS AND METHODS Twenty-five subjects were enrolled in the study. Picato (ingenol mebutate) (LEO Pharma, Parsippany, NJ) gel was applied to an area with a known actinic keratosis daily for 3 days. Subjects self-evaluated and were investigator evaluated on 6 characteristics on Days 7, 30, and 60 using an objective scale. The scale evaluated actinic keratosis, overall skin appearance, wrinkling, dyschromia, erythema, and texture. The subjects were also evaluated using the Griffiths' Photonumeric Photoaging Scale for overall improvement. RESULTS Twenty-two subjects completed the clinical study and demonstrated statistically significant improvement by Day 60 in actinic keratosis, overall skin appearance, wrinkling, dyschromia, erythema, and texture (p < .05). CONCLUSION Topical ingenol mebutate 0.015% gel produces cosmetic improvement of photoaged skin within 60 days of application.