A New, Objective, Quantitative Scale for Measuring Local Skin Responses Following Topical Actinic Keratosis Therapy with Ingenol Mebutate
Tóm tắt
Từ khóa
Tài liệu tham khảo
Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000;42:4–7.
Misiewicz J, Sendagorta E, Golebiowska A, Lorenc B, Czarnetzki BM, Jablonska S. Topical treatment of multiple actinic keratoses of the face with arotinoid methyl sulfone (Ro 14-9706) cream versus tretinoin cream: a double-blind, comparative study. J Am Acad Dermatol. 1991;24:448–51.
Grimaitre M, Etienne A, Fathi M, Piletta PA, Saurat JH. Topical colchicine therapy for actinic keratoses. Dermatology. 2000;200:346–8.
Jorizzo JL. Current and novel treatment options for actinic keratosis. J Cutan Med Surg. 2005;8(Suppl 3):13–21.
Lebwohl M, Dinehart S, Whiting D, et al. Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. J Am Acad Dermatol. 2004;50:714–21.
LEO Pharma. Picato® (ingenol mebutate) gel, 0.015%, 0.05%. Prescribing information: www.picato.com/_pdf/PrescribingInformation.pdf . Last accessed February 6, 2014.
LEO Pharma. Picato 150 micrograms/gram gel. Summary of product characteristics: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002275/WC500135327.pdf . Last accessed April 26, 2013.
Food and Drug Administration (FDA). Memorandum of meeting minutes. Pre-phase 2 guidance meeting for IND 70,114, PEP005 topical gel for topical treatment of actinic keratoses. USA: FDA Communication; 2006.
Freeman M, Oakley A, Siller G, et al. Study to determine the optimal tolerated regimen of ingenol mebutate (PEP005) gel for actinic keratosis of the face or face and scalp. Poster P2010 presented at the American Academy of Dermatology (AAD) Summer Academy Meeting, Chicago, IL, USA, July 30 to August 3, 2008.
Spencer J. Multicenter, randomized, double-blind, vehicle-controlled, dose-ranging study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel 0.005%, 0.01%, and 0.015% when used to treat actinic keratoses on the head. J Am Acad Dermatol. 2010;62(3 Suppl 1):AB105 (Poster P2913).
Anderson L, Schmieder GJ, Werschler WP, et al. Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. J Am Acad Dermatol. 2009;60:934–43.
Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012;366:1010–9.
Steffen E, Bertsch HP, Haenssle HA, Zibert JR, Schön M, Schön MP. Pharmacodynamics of ingenol mebutate 0.05% gel for the treatment of actinic keratosis assessed by histology. J Am Acad Dermatol. 2013;68(4 Suppl 1):AB163 (Abstract P6969).
Ulrich M, Völker-Call M, Lange-Asschenfeldt S, et al. Assessment of the in vivo effects of ingenol mebutate 0.05% gel for the treatment of actinic field cancerization by reflectance confocal microscopy. Poster 334 presented at the 10th Meeting of the International Confocal Working Group (ICWG), Prague, Czech Republic, September 28, 2012.
Berman B, Swanson N, Goldenberg G, et al. Field treatment with ingenol mebutate gel, 0.015%, 3 weeks after cryosurgery of actinic keratosis is safe and effective. Poster at the Winter Clinical Dermatology Conference of the American Academy of Dermatology, Koloa, HI, USA, January 18–23, 2013.
Ramsay JR, Suhrbier A, Aylward JH, et al. The sap from Euphorbia peplus is effective against human nonmelanoma skin cancers. Br J Dermatol. 2011;164:633–6.
Spencer J. Multicenter, randomized, double-blind, vehicle-controlled, dose-ranging study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel 0.005%, 0.01%, and 0.015% when used to treat actinic keratoses on the head. Poster P2913 at the 68th Annual Meeting of the American Academy of Dermatology (AAD), Miami, FL, USA, March 5–9, 2010.
Sinnya S, McEniery E, Soyer HP, Tan J-M, Oesterdal ML. Safety of LEO 43204 in a first in man trial of actinic keratosis on the forearms. J Am Acad Dermatol. 2014;70(Suppl):AB139 (Abstract P7942).
Freeman M, Rosen R, Zibert JR, Knudsen KM, Spelman L. Ingenol mebutate gel topically applied under occlusion to superficial basal cell carcinoma is efficacious compared with marginal effect in seborrheic keratosis. J Am Acad Dermatol. 2014;70(Suppl):AB136 (Poster 7934).