Safety and efficacy of escalating doses of ingenol mebutate for field treatment of actinic keratosis on the full face, full balding scalp, or chest

C. William Hanke, Brian Berman, Neil Swanson, David M. Pariser, Jonathan S. Weiss, Michael Bukhalo, Torsten Skov, John Villumsen, Daniel Siegel

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Background: Actinic keratosis (AK) can affect large skin areas. Ingenol mebutate (IngMeb) gel (0.015% and 0.05%) is approved for topical treatment of AK in a single contiguous area of ~25 cm2. Objective: The study sought to determine the maximum tolerated dose (MTD), efficacy, and tolerability of IngMeb applied to AK on a contiguous area less than equal to 250 cm2. Methods: Part 1 determined the MTD of IngMeb at 7 concentrations for 2 or 3 days. Part 2 assessed efficacy and tolerability at the MTD and one dose lower for 2 or 3 days vs vehicle. Results: Four dosing regimens with an acceptable benefit-to-risk ratio were identified: 0.018% and 0.027% once daily for 2 or 3 days. Complete clearance at 8 weeks was achieved by 21.3% to 39.1% of IngMeb-treated patients vs 0% to 3.2% treated with vehicle. Composite local skin response scores peaked on the day after the last application, rapidly declined, and were near baseline at 2 weeks. Adverse events were predominantly mild or moderate. Limitations: The study evaluated a limited number of doses in a population of only white patients. Conclusion: IngMeb gel was effective and well tolerated as field treatment of AK on the full face, full scalp, and up to 250 cm2 on the chest. D

Original languageEnglish (US)
Pages (from-to)438-444
Number of pages7
JournalJournal of Drugs in Dermatology
Volume16
Issue number5
StatePublished - May 1 2017

ASJC Scopus subject areas

  • Dermatology

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    Hanke, C. W., Berman, B., Swanson, N., Pariser, D. M., Weiss, J. S., Bukhalo, M., Skov, T., Villumsen, J., & Siegel, D. (2017). Safety and efficacy of escalating doses of ingenol mebutate for field treatment of actinic keratosis on the full face, full balding scalp, or chest. Journal of Drugs in Dermatology, 16(5), 438-444.