Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-Week results

Brian Berman, Gary Goldenberg, C. William Hanke, Stephen K. Tyring, Wm Philip Werschler, Kim Mark Knudsen, Joana Goncalves, Thomas Larsson, Torsten Skov, Neil Swanson

Research output: Contribution to journalArticle

24 Scopus citations

Abstract

INTRODUCTION: Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions. METHODS: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle. RESULTS: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated. CONCLUSIONS: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.

Original languageEnglish (US)
Pages (from-to)154-160
Number of pages7
JournalJournal of Drugs in Dermatology
Volume13
Issue number2
StatePublished - Feb 2014

ASJC Scopus subject areas

  • Dermatology

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    Berman, B., Goldenberg, G., Hanke, C. W., Tyring, S. K., Werschler, W. P., Knudsen, K. M., Goncalves, J., Larsson, T., Skov, T., & Swanson, N. (2014). Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-Week results. Journal of Drugs in Dermatology, 13(2), 154-160.