Assessment of Efficacy and Irritation of Ingenol Mebutate Gel 0.015% Used with or Without Dimethicone Lotion for Treatment of Actinic Keratosis on the Face
Jim On, S.C.; Hashim, P.W.; Nia, J.K.; Lebwohl, M.G.
Journal of Drugs in Dermatology Jdd 16(5): 432-436
2017
ISSN/ISBN: 1545-9616 PMID: 28628678 Document Number: 17065
Background: Ingenol mebutate gel 0.015% provides high clearance rates for actinic keratosis (AK) on the face and scalp but causes transient local skin responses (LSRs). Objective: This study sought to determine whether the application of 1% dimethicone would decrease ingenol mebutate-associated LSRs and/or affect efficacy during the treatment of multiple AKs on the face. Methods: Ingenol mebutate gel 0.015% was applied for 3 days to two 25 cm2 areas, each containing 3 to 8 AKs on the face of each subject, followed by application of 1% dimethicone lotion in an investigator-blinded manner to one randomly selected AK-containing area until LSRs were no longer present. Results: In total, 20 subjects were enrolled and completed the study. Topical 1% dimethicone lotion applied during and after treatment of facial AK with ingenol mebutate gel 0.015% reduced mean total LSR scores at days 8 and 15 compared with ingenol mebutate gel only, although the difference was not statistically significant. Efficacy was equivalent between the two treatment arms. Limitations: The study evaluated a relatively small number of subjects, all of whom were white. Conclusions: The application of 1% dimethicone following ingenol mebutate gel 0.015% produced a trend toward lower severity of some LSRs, with no difference in efficacy.
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