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

Handler, Marc, Z., MD*,†; Bloom, Bradley, S., MD*,‡; Goldberg, David, J., MD, JD*,†,§

doi: 10.1097/DSS.0000000000001269
Original Article

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.

*Skin Laser & Surgery Specialists of NY and NJ, New York, New York;

Dermatology, Rutgers University New Jersey Medical School, Newark, New Jersey;

Department of Dermatology, New York University, New York, New York;

§Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York, New York

Address correspondence and reprint requests to: Marc Z. Handler, MD, Skin Laser & Surgery Specialists of NY and NJ, 20 Prospect Avenue, Suite 702, Hackensack, New Jersey 07601, or e-mail:

The authors have indicated no significant interest with commercial supporters.

© 2018 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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