Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results

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

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Introduction: Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery. Methods: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients =18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. Results: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P=.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P=.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. Conclusions: Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.

Original languageEnglish (US)
Pages (from-to)741-747
Number of pages7
JournalJournal of Drugs in Dermatology
Volume13
Issue number6
StatePublished - 2014

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Actinic Keratosis
Cryosurgery
Gels
Safety
Therapeutics
3-ingenyl angelate
Scalp
Recurrence

ASJC Scopus subject areas

  • Dermatology
  • Medicine(all)

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 after cryosurgery of actinic keratosis: 12-month results. Journal of Drugs in Dermatology, 13(6), 741-747.

Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis : 12-month results. / Berman, Brian; Goldenberg, Gary; Hanke, C. William; Tyring, Stephen K.; Werschler, Wm Philip; Knudsen, Kim Mark; Larsson, Thomas; Swanson, Neil.

In: Journal of Drugs in Dermatology, Vol. 13, No. 6, 2014, p. 741-747.

Research output: Contribution to journalArticle

Berman, B, Goldenberg, G, Hanke, CW, Tyring, SK, Werschler, WP, Knudsen, KM, Larsson, T & Swanson, N 2014, 'Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results', Journal of Drugs in Dermatology, vol. 13, no. 6, pp. 741-747.
Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM et al. Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results. Journal of Drugs in Dermatology. 2014;13(6):741-747.
Berman, Brian ; Goldenberg, Gary ; Hanke, C. William ; Tyring, Stephen K. ; Werschler, Wm Philip ; Knudsen, Kim Mark ; Larsson, Thomas ; Swanson, Neil. / Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis : 12-month results. In: Journal of Drugs in Dermatology. 2014 ; Vol. 13, No. 6. pp. 741-747.
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abstract = "Introduction: Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery. Methods: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients =18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015{\%} or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. Results: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5{\%} vs 49.4{\%}; P=.04; month 12: 30.5{\%} vs 18.5{\%}; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9{\%} vs 51.9{\%}; P=.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2{\%} vs 54.1{\%}; P=.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78{\%} vs 68{\%} at 6 months; 64{\%} vs 57{\%} at 9 months; 55{\%} vs 40{\%} at month 12, respectively. Ingenol mebutate 0.015{\%} gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. Conclusions: Field treatment with ingenol mebutate 0.015{\%} gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015{\%} gel following cryosurgery reduced development of new lesions in the treated field.",
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T1 - Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis

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AU - Berman, Brian

AU - Goldenberg, Gary

AU - Hanke, C. William

AU - Tyring, Stephen K.

AU - Werschler, Wm Philip

AU - Knudsen, Kim Mark

AU - Larsson, Thomas

AU - Swanson, Neil

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N2 - Introduction: Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery. Methods: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients =18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. Results: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P=.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P=.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. Conclusions: Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.

AB - Introduction: Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery. Methods: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients =18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months. Results: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P=.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P=.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment. Conclusions: Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.

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