Efficacy of a film-forming medical device containing sunscreen (50+) and piroxicam 0.8% in actinic keratosis and field cancerization: a multicenter, assessor-blinded, 3 month trial

References

• Röwert-Huber J, Patel MJ, Forschner T, et al. Actinic keratosis is an early in situ squamous cell carcinoma: a proposal for reclassification. Br J Dermatol 2007;156:8-12
   PubMed Web of Science ®Google Scholar
• Ziegler A, Jonason AS, Leffell DJ, Simon JA. Sunburn and p53 in the onset of skin cancer. Nature 1994;372:773
   PubMed Web of Science ®Google Scholar
• Anwar J, Wrone DA, Kimyai-Asadi A, Alam M. The development of actinic keratosis into invasive squamous cell carcinoma: evidence and evolving classification schemes. Clin Dermatol 2004;22:189-96
   PubMed Web of Science ®Google Scholar
• Glogau RG. The risk of progression to invasive disease. J Am Acad Dermatol 2000;42:23-4
   PubMed Web of Science ®Google Scholar
• Peris K, Calzavara-Pinton PG, Neri L, et al. Italian expert consensus for the management of actinic keratosis in immunocompetent patients. J Eur Acad Dermatol Venereol 2016;30:1077-84
   PubMed Web of Science ®Google Scholar
• Fernandez Figueras MT. From actinic keratosis to squamous cell carcinoma: pathophysiology revisited. J Eur Acad Dermatol Venereol 2017;31:5-7
   PubMed Web of Science ®Google Scholar
• Stockfleth E, Kerl H. Guidelines for the management of actinic keratoses. Eur J Dermatol 2006;16:599-606
   PubMed Web of Science ®Google Scholar
• Buckman SY, Gresham A, Hale P, et al. COX-2 expression is induced by UVB exposure in human skin: implications for the development of skin cancer. Carcinogenesis 1998;19:723-9
   PubMed Web of Science ®Google Scholar
• Seed MP, Freemantle CN, Alam CA, et al. Apoptosis induction and inhibition of colon-26 tumour growth and angiogenesis: findings on COX-1 and COX-2 inhibitors in vitro & in vivo and topical diclofenac in hyaluronan. Sinzinger H., Samuelsson B., Vane S.J.R., Paoletti R., Ramwell P., Wong P.Y.-K. (Eds.) In: Recent Advances in Prostaglandin, Thromboxane, and Leukotriene Research. Berlin, Germany: Springer US, 1997:339-42
   Google Scholar
• Nelson C, Rigel D, Smith S, et al. Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze). J Drugs Dermatol 2003;3:401-7
   Google Scholar
• Campione E, Diluvio L, Paterno EJ, Chimenti S. Topical treatment of actinic keratoses with piroxicam 1% gel. Am J Clin Dermatol 2010;11:45-50
   PubMed Web of Science ®Google Scholar
• Babino G, Diluvio L, Bianchi L, et al. Long-term use of a new topical formulation containing piroxicam 0.8% and sunscreen: efficacy and tolerability on actinic keratosis. A proof of concept study. Curr Med Res Opin 2016;32:1345-9
   PubMed Web of Science ®Google Scholar
• Olsen EA, Abernethy ML, Kulp-Shorten C, et al. A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol 1991;24:738-43
   PubMed Web of Science ®Google Scholar
• Feldman SR, Fleischer AB, Williford PM, Jorizzo JL. Destructive procedures are the standard of care for treatment of actinic keratoses. J Am Acad Dermatol 1999;40:43-7
   PubMed Web of Science ®Google Scholar
• Stockfleth E, Ferrandiz C, Grob JJ, et al. Development of a treatment algorithm for actinic keratoses: a European consensus. Eur J Dermatol 2008;18:651-9
   PubMed Web of Science ®Google Scholar
• Stockfleth E, Peris K, Guillen C, et al. A consensus approach to improving patient adherence and persistence with topical treatment for actinic keratosis. Int J Dermatol 2015;54:509-15
   PubMed Web of Science ®Google Scholar
• Vatve M, Ortonne JP, Birch-Machin MA, Gupta G. Management of field change in actinic keratosis. Br J Dermatol 2007;157:21-4
   PubMed Web of Science ®Google Scholar
• Clouser MC, Roe DJ, Foote JA, Harris RB. Effect of non-steroidal anti-inflammatory drugs on non-melanoma skin cancer incidence in the SKICAP-AK trial. Pharmacoepidemiol Drug Saf 2009;18:276-83
   PubMed Web of Science ®Google Scholar
• Zha S, Yegnasubramanian V, Nelson WG, et al. Cyclooxygenases in cancer: progress and perspective. Canc Lett 2004;215:1-20
   PubMed Web of Science ®Google Scholar
• Micali G, Lacarrubba F, Dinotta F, et al. Treating skin cancer with topical cream. Expet Opin Pharmacother 2010;11:1515-27
   PubMed Web of Science ®Google Scholar
• Brogden RN, Heel RC, Speight TM, Avery GS. Piroxicam. Drugs 1984;28:292-323
   PubMed Web of Science ®Google Scholar
• Hawkey CJ. COX-1 and COX-2 inhibitors. Best Pract Res Clin Gastroenterol 2001;15:801-20
   PubMed Web of Science ®Google Scholar
• Reddy BS, Nayini J, Tokumo K, et al. Chemoprevention of colon carcinogenesis by concurrent administration of piroxicam, a nonsteroidal antiinflammatory drug with d, l-α-difluoromethylornithine, an ornithine decarboxylase inhibitor, in diet. Canc Res 1990;50:2562-8
   PubMed Web of Science ®Google Scholar
• Pairet M, Engelhardt G. Differential inhibition of COX-1 and COX-2 in vitro and pharmacological profile in vivo of NSAIDs. Vane J, Botting J and Botting R (Eds) In: Improved Non-Steroid Anti-Inflammatory Drugs: COX-2 Enzyme Inhibitors. Netherlands Dordrecht: Springer, 1996:103-19
   Google Scholar
• Mirshafiey A, Vaezzadeh F, Khorramizadeh MR, Saadat F. Effect of piroxicam on matrix metalloproteinase 2 and apoptosis. Int J Tissue Reactions 2003;26:1-7
   Google Scholar
• Mazumder MK, Bhattacharya P, Borah A. Inhibition of matrix metalloproteinase-2 and 9 by piroxicam confer neuroprotection in cerebral ischemia: an in silico evaluation of the hypothesis. Med Hypotheses 2014;83:697-701
   PubMed Web of Science ®Google Scholar
• Schmalfeldt B, Prechtel D, Härting K, et al. Increased expression of matrix metalloproteinases (MMP)-2, MMP-9, and the urokinase-type plasminogen activator is associated with progression from benign to advanced ovarian cancer. Clin Canc Res 2001;7:2396-404
   PubMed Web of Science ®Google Scholar
• Liu G, Ma WY, Bode AM, et al. NS-398 and piroxicam suppress UVB-induced activator protein 1 activity by mechanisms independent of cyclooxygenase-2. J Biol Chem 2003;278:2124-30
   PubMed Web of Science ®Google Scholar
• Naylor MF, Farmer KC. The case for sunscreens: a review of their use in preventing actinic damage and neoplasia. Arch Dermatol 1997;133:1146-54
   PubMedGoogle Scholar
• Kligman LH, Akin FJ, Kligman AM. Sunscreens prevent ultraviolet photocarcinogenesis. J Am Acad Dermatol 1980;3:30-5
   PubMed Web of Science ®Google Scholar
• Thompson SC, Jolley D, Marks R. Reduction of solar keratoses by regular sunscreen use. N Engl J Med 1993;329:1147-51
   PubMed Web of Science ®Google Scholar
• Nelson C, Rigel D, Smith S, et al. Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze). J Drugs Dermatol 2003;3:401-7
   Google Scholar
• Scotti E, Deledda S, Milani M. Efficacy of a film-forming medical device containing piroxicam and sun filters in the treatment of multiple actinic keratosis lesions in a subject with a history of kaposi sarcoma. Case Rep Dermatol 2016;8:254-61
   PubMed Web of Science ®Google Scholar
• Jarvis B, Figgitt DP. Topical 3% diclofenac in 2.5% hyaluronic acid gel. Am J Clin Dermatol 2003;4:203-13
   PubMed Web of Science ®Google Scholar
• Soraraze Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/21229, Last accessed January 2017
   Google Scholar
• Darlington S, Williams G, Neale R, et al. A randomized controlled trial to assess sunscreen application and beta carotene supplementation in the prevention of solar keratoses. Arch Dermatol 2003;139:451-5
   PubMed Web of Science ®Google Scholar