Safety and Efficacy of Escalating Doses of Ingenol Mebutate for Field Treatment of Actinic Keratosis on the Full Face, Full Balding Scalp, or Chest
May 2017 | Volume 16 | Issue 5 | Original Article | 438 | Copyright © May 2017
C. William Hanke MD MPH FACP,a Brian Berman MD PhD,b Neil Swanson MD,c David M. Pariser MD,d Jonathan S. Weiss MD,e Michael Bukhalo MD,f Torsten Skov MD PhD,g John Villumsen MSc,g and Daniel Siegel MDh
aThe Laser Skin and Skin Surgery Center of Indiana, Carmel, IN bCenter for Clinical and Cosmetic Research, Aventura, FL cOregon Health and Science University, Portland, OR dEastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA eGwinnett Dermatology, Snellville, GA fArlington Dermatology, Arlington Heights, IL gLEO Pharma A/S, Ballerup, Denmark hLong Island Skin Cancer & Dermatologic Surgery, Smithtown, NY
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.
J Drugs Dermatol. 2017;16(5):438-444.