New topical treatment options for actinic keratosis: A systematic review

Acta Dermato-Venereologica

Volumn 96, Issue 1, 2016, Pages 17-22

  Stockfleth, Eggert ^a   Sibbring, Gillian C ^b   Alarcon, Ivette ^c  

^a ST JOSEF HOSPITAL   (Germany)

^b Complete Clarity ^*  (United Kingdom)

^c HOSPITAL CLÍNIC   (Spain)

Author keywords

5 fluorouracil; Imiquimod; Ingenol mebutate; Salicylic acid; Skin cancer; Sustained clearance

Indexed keywords

FLUOROURACIL; IMIQUIMOD; INGENOL MEBUTATE; SALICYLIC ACID; TOPICAL AGENT; 3-INGENYL ANGELATE; AMINOQUINOLINE DERIVATIVE; DERMATOLOGICAL AGENT; DITERPENE; DRUG COMBINATION;

ACTINIC KERATOSIS; ARTICLE; CLINICAL OUTCOME; DRUG CLEARANCE; DRUG EFFICACY; DRUG SCREENING; HUMAN; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; RECURRENCE RISK; SYSTEMATIC REVIEW; TOPICAL TREATMENT; TREATMENT DURATION; CUTANEOUS DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; FACIAL DERMATOSES; KERATOSIS, ACTINIC; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCALP DERMATOSES; SKIN; TREATMENT OUTCOME;

ADMINISTRATION, CUTANEOUS; AMINOQUINOLINES; DERMATOLOGIC AGENTS; DITERPENES; DRUG COMBINATIONS; FACIAL DERMATOSES; FLUOROURACIL; HUMANS; KERATOSIS, ACTINIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SALICYLIC ACID; SCALP DERMATOSES; SKIN; TREATMENT OUTCOME;

EID: 85018229026     PISSN: 00015555     EISSN: 16512057     Source Type: Journal    
DOI: 10.2340/00015555-2167     Document Type: Article

References (48)

1. Ramsay HM, Fryer AA, Hawley CM, Smith AG, Nicol DL, Harden PN. Factors associated with nonmelanoma skin cancer following renal transplantation in Queensland, Australia. J Am Acad Dermatol 2003; 49: 397–406.
2. Cockerell CJ. Histopathology of incipient intraepidermal squamous cell carcinoma (“actinic keratosis”). J Am Acad Dermatol 2000; 42: 11–17.
3. Feldman SR, Fleischer AB, Jr.. Progression of actinic keratosis to squamous cell carcinoma revisited: clinical and treatment implications. Cutis 2011; 87: 201–207.
4. Guideline Subcommittee “Actinic Keratoses” of the European Dermatology Forum. Guideline on Actinic Keratosis. Available from: http://www.euroderm.org/index.php/edf-guidelines.
5. de Berker D, McGregor JM, Hughes BR. Guidelines for the management of actinic keratoses. Br J Dermatol 2007; 156: 222–230.
6. Del Rosso JQ. Current regimens and guideline implications for the treatment of actinic keratosis: proceedings of a clinical roundtable at the 2011 Winter Clinical Dermatology Conference. Cutis 2011; 88: Suppl 1–8.
7. Gupta AK, Paquet M, Villanueva E, Brintnell W. Interventions for actinic keratoses. Cochrane Database Syst Rev 2012; 12.
8. Stockfleth E, Ferrandiz C, Grob JJ, Leigh I, Pehamberger H, Kerl H. Development of a treatment algorithm for actinic keratoses: a European Consensus. Eur J Dermatol 2008; 18: 651–659.
9. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700.
10. Olsen EA, Abernethy ML, Kulp-Shorten C, Callen JP, Glazer SD, Huntley A, 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: 738–743.
11. EBSCO. Available from: http://www.ebscohost.com/.
12. ProQuest Dialog. Available from: http://search.proquest.com/.
13. Higgins JPT, Green S. (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011] The Cochrane Collaboration, 2011. Available from: www.cochrane-handbook.org.
14. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 2009; 6: e1000097.
15. Weiss J, Zibert JR. Measurement of patient satisfaction and the characterization of application-site pain with ingenol mebutate 150mcg/g gel in patients treated on the face or scalp. J Dtsch Dermatol Ges 2013; 11: 946–947.
16. Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol 2013; 149: 666–670.
17. Stockfleth E, Zwingers T, Willers C. Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. Eur J Dermatol 2012; 22: 370–374.
18. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med 2012; 366: 1010–1019.
19. Hanke CW, Beer KR, Stockfleth E, Wu J, Rosen T, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles. J Am Acad Dermatol 2010; 62: 573–581.
20. Swanson N, Abramovits W, Berman B, Kulp J, Rigel DS, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 2-week cycles. J Am Acad Dermatol 2010; 62: 582–590.
21. Siller G, Gebauer K, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study. Australas J Dermatol 2009; 50: 16–22.
22. Stockfleth E, Kerl H, Zwingers T, Willers C. Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol 2011; 165: 1101–1108.
23. Spencer J. Multicenter, randomized, double-blind, vehiclecontrolled, 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). 68th Annual Meeting of the American Academy of Dermatology, Miami, FL, USA, 2010 Mar 5–9.
24. Berman B, Marmur E, Larsson T, Melgaard A. Three-day topical treatment with ingenol mebutate gel 0.015% for actinic keratoses on the face and scalp: analysis of data pooled from two trials (Poster P5623). 70th Annual Meeting of the American Academy of Dermatology, San Diego, CA, USA, 2012 Mar 16–20.
25. Lebwohl M, Swanson N, Kobayashi K, Melgaard A. Local skin responses associated with ingenol mebutate gel for the treatment of actinic keratosis: two analyses of pooled data (Poster P4997). 70th Annual Meeting of the American Academy of Dermatology, San Diego, CA USA, 2012 Mar 16–20.
26. Swanson N, Smith CC, Kaur M, Goldenberg G. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: two phase 3 multicenter, randomized, double-blind, placebocontrolled studies. J Drugs Dermatol 2013; 12: 1278–1282.
27. Gupta A, Paquet M. Mixed treatment comparisons metaanalysis of interventions for actinic keratosis. J Am Acad Dermatol 2013; 68: AB162.
28. Berman B, Melgaard A, Marmur E, Larsson T.: Three-day topical treatment with ingenol mebutate gel, 0.015% for actinic keratoses on the face and scalp: Analysis of data pooled from two trials. J Am Acad Dermatol 2012; 66: AB3.
29. Lebwohl M, Melgaard A, Kobayashi K, Swanson N. Local skin responses associated with ingenol mebutate gel for the treatment of actinic keratosis: Two analyses of pooled data. J Am Acad Dermatol 2012; 66: AB153.
30. Stockfleth E, Ulrich M, Kerl H, Willers C. Long-term sustained efficacy of low dose 5-fluorouracil combined with 10% salicylic acid as a lesion directed treatment for actinic keratoses. Melanoma Res 2011; 21: e53.
31. Gupta AK, Villanueva E, Brintnell W, Paquet M. Interventions for actinic keratosis: a Cochrane review (Poster). 70th Annual Meeting of the American Academy of Dermatology, San Diego, CA, USA, 2012 Mar 16–20.
32. Gupta AK, Paquet M. Mixed treatment comparisons metaanalysis of interventions for actinic keratosis (Poster). 71st Annual Meeting of the American Academy of Dermatology, Miami, FL, USA, 2013 Mar 1–5.
33. European Medicines Agency. Assessment Report Picato. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002275/WC500135329.pdf.
34. European Medicines Agency. Assessment Report Zyclara. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002387/WC500132263.pdf.
35. European Medicines Agency. Zyclara Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002387/WC500132261.pdf.
36. European Medicines Agency. Picato Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002275/WC500135327.pdf.
37. European Medicines Consortium. Actikerall Summary of Product Characteristics. Available from: http://www.medicines.org.uk/emc/medicine/24614/SPC/Actikerall%205mg%20g%20+%20100mg%20g%20Cutaneous%20Solution/.
38. Scottish Medicines Consortium. Actikerall advice document. Available from: http://www.scottishmedicines.org.uk/files/advice/fluorouracil_and_salicylic_acid_Actikerall_FINAL_September_2011_for_website.pdf.
39. Swanson N, Stein Gold L, Larsson T, Melgaard A. Longterm follow-up studies of ingenol mebutate gel for the treatment of actinic keratosis. Fall Clinical Dermatology Las Vegas, NV, USA, 2011 Oct 27–30.
40. Quaedvlieg PJ, Tirsi E, Thissen MR, Krekels GA. Actinic keratosis: how to differentiate the good from the bad ones? Eur J Dermatol 2006; 16: 335–339.
41. Suchniak JM, Baer S, Goldberg LH. High rate of malignant transformation in hyperkeratotic actinic keratoses. J Am Acad Dermatol 1997; 37: 392–394.
42. US Food and Drug Administration. Center For Drug Evaluation and Research. Medical Review. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202833Orig1s000MedR.pdf.
43. Swanson BN. Medical use of dimethyl sulfoxide (DMSO). Rev Clin Basic Pharm 1985; 5: 1–33.
44. Gupta AK, Paquet M. Network meta-analysis of the outcome ‘participant complete clearance’ in nonimmunosuppressed participants of eight interventions for actinic keratosis: a follow-up on a Cochrane review. Br J Dermatol 2013; 169: 250–259.
45. Gupta AK, Paquet M. Ingenol mebutate: a promising treatment for actinic keratoses and nonmelanoma skin cancers. J Cutan Med Surg 2013; 17: 173–179.
46. Nashan D, Meiss F, Müller M. Therapeutic strategies for actinic keratosis – a systematic review. Eur J Dermatol 2013; 23: 14–32.
47. Ghuznavi N, Nocera NF, Guajardo AR, Weinberg JM. Emerging medical treatments for actinic keratoses, squamous cell carcinoma and basal cell carcinoma. Clin Invest 2012; 2: 909–921.
48. García C. Imiquimod in cutaneous oncology. Dermatologia Revista Mexicana 2009; 53: 167–172.