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

23 Citations (Scopus)

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 - 2014

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Actinic Keratosis
Cryosurgery
Gels
Safety
3-ingenyl angelate
Therapeutics
Scalp
Double-Blind Method
Nitrogen

ASJC Scopus subject areas

  • Dermatology

Cite this

Berman, B., Goldenberg, G., Hanke, C. W., Tyring, S. K., Werschler, W. P., Knudsen, K. M., ... 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.

Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis : 11-Week results. / Berman, Brian; Goldenberg, Gary; Hanke, C. William; Tyring, Stephen K.; Werschler, Wm Philip; Knudsen, Kim Mark; Goncalves, Joana; Larsson, Thomas; Skov, Torsten; Swanson, Neil.

In: Journal of Drugs in Dermatology, Vol. 13, No. 2, 2014, p. 154-160.

Research output: Contribution to journalArticle

Berman, B, Goldenberg, G, Hanke, CW, Tyring, SK, Werschler, WP, Knudsen, KM, 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, vol. 13, no. 2, pp. 154-160.
Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM et al. Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-Week results. Journal of Drugs in Dermatology. 2014;13(2):154-160.
Berman, Brian ; Goldenberg, Gary ; Hanke, C. William ; Tyring, Stephen K. ; Werschler, Wm Philip ; Knudsen, Kim Mark ; Goncalves, Joana ; Larsson, Thomas ; Skov, Torsten ; Swanson, Neil. / Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis : 11-Week results. In: Journal of Drugs in Dermatology. 2014 ; Vol. 13, No. 2. pp. 154-160.
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N2 - 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.

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