Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5-fluorouracil cream for the treatment of facial actinic keratosis: A prospective randomized trial

Journal of the European Academy of Dermatology and Venereology

Volumn 29, Issue 9, 2015, Pages 1822-1827

  Samorano, L P ^a   Torezan, L A ^a   Sanches, J A ^a  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; INGENOL MEBUTATE; 3-INGENYL ANGELATE; DITERPENE; GEL; IMMUNOSUPPRESSIVE AGENT;

ACTINIC KERATOSIS; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CONJUNCTIVAL HYPEREMIA; CONTROLLED STUDY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EYELID EDEMA; FACE; FEMALE; HUMAN; INTENTION TO TREAT ANALYSIS; LOCAL SKIN REACTION; MAJOR CLINICAL STUDY; MALE; PAIN; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; VERY ELDERLY; DRUG TOLERANCE; FACIAL DERMATOSES; FOLLOW UP; GEL; KERATOSIS, ACTINIC; PROSPECTIVE STUDY; TIME FACTOR; TOPICAL DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADMINISTRATION, TOPICAL; DITERPENES; DRUG TOLERANCE; FACIAL DERMATOSES; FLUOROURACIL; FOLLOW-UP STUDIES; GELS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KERATOSIS, ACTINIC; PROSPECTIVE STUDIES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84940202257     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/jdv.13063     Document Type: Article

References (27)

1. Feldman SR, Fleischer AB Jr,. Progression of actinic keratosis to squamous cell carcinoma revisited: clinical and treatment implications. Cutis 2011; 87: 201-207.
2. Marks R,. Malignant transformation of solar keratoses to SCC. Lancet 1988; 1: 795-797.
3. Callen JP, Bickers DR, Moy RL,. Actinic keratoses. J Am Acad Dermatol 1997; 36: 650-653.
4. Ulrich C,. Topical treatment of field cancerization. Cancer Treat Res 2009; 146: 439-446.
5. Kanjilal S, Strom SS, Clayman GL, et al,. p53 mutations in \melanoma skin cancer of the head and neck: molecular evidence for field cancerization. Cancer Res 1995; 55: 3604-3609.
6. Szeimies RM, Torezan L, Niwa A, et al,. Clinical, histopathological and immunohistochemical assessment of human skin field cancerization before and after photodynamic therapy. Br J Dermatol 2012; 167: 150-159.
7. Quaedvlieg PJ, Tirsi E, Thissen MR, et al,. Actinic keratosis: how to differentiate the good from the bad ones? Eur J Dermatol 2006; 16: 335-339.
8. de Berker D, McGregor JM, Hughes BR,. Guidelines for the management of actinic keratoses. Br J Dermatol 2007; 156: 222-230.
9. McIntyre WJ, Downs MR, Bedwell SA,. Treatment options for actinic keratoses. Am Fam Physician 2007; 76: 667-671.
10. Stockfleth E, Kerl H,. Guidelines for the management of actinic keratoses. Eur J Dermatol 2006; 16: 599-606.
11. Tutrone WD, Saini R, Caglar S, et al,. Topical therapy for actinic keratoses, I: 5-Fluorouracil and imiquimod. Cutis 2003; 71: 365-370.
12. Hohmann J, Evanics F, Berta L, et al,. Diterpenoids from Euphorbia peplus. Planta Med 2000; 66: 291-294.
13. Rosen RH, Gupta AK, Tyring SK,. Dual mechanism of action of ingenol mebutate gel for topical treatment of actinic keratoses: rapid lesion necrosis followed by lesion-specific immune response. J Am Acad Dermatol 2012; 66: 486-493.
14. Lebwohl M, Swanson N, Anderson LL, et al,. Ingenol mebutate gel for actinic keratosis. N Engl J Med 2012; 366: 1010-1019.
15. Lebwohl M, Shumack S, Stein Gold L, et al,. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol 2013; 149: 666-670.
16. Berman B, Melgaard A, Marmur E, et al,. 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 (Suppl 1): AB3.
17. Lebwohl M, Melgaard A, Kobayashi K, et al,. 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 (Suppl 1): AB153.
18. Lawrence A, Melgaard A, Schmeider G, et al,. Two-day topical treatment with ingenol mebutate gel, 0.05% for actinic keratoses on the trunk and extremities: analysis of data pooled from two trials. J Am Acad Dermatol 2012; 66 (Suppl 1): AB159.
19. Klein E, Milgrom H, Helm F, et al,. Tumors of the skin: effects of local use of cytostatic agents. Skin (Los Angeles) 1962; 1: 81-87.
20. Klein E, Stoll HL, Miller E, et al,. The effects of 5-fluorouracil (5-FU) ointment in the treatment of neoplastic dermatoses. Dermatologica 1970; 140 (Suppl. 1): 21-33.
21. Askew DA, Mickan SM, Soyer HP, et al,. Effectiveness of 5-fluorouracil treatment for actinic keratosis-a systematic review of randomized controlled trials. Int J Dermatol 2009; 48: 453-463.
22. Smith SR, Morhenn VB, Piacquadio DJ,. Bilateral comparison of the efficacy and tolerability of 3% diclofenac sodium gel and 5% 5-fluorouracil cream in the treatment of actinic keratoses of the face and scalp. J Drugs Dermatol 2006; 5: 156-159.
23. Kurwa HA, Yong-Gee SA, Seed PT, et al,. A randomized paired comparison of photodynamic therapy and topical 5-fluorouracil in the treatment of actinic keratoses. J Am Acad Dermatol 1999; 41: 414-418.
24. Yentzer B, Hick J, Williams L, et al,. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol 2009; 145: 203-205.
25. Loven K, Stein L, Furst K, Levy S,. Evaluation of the efficacy and tolerability of 0.5% fluorouracil cream and 5% fluorouracil cream applied to each side of the face in patients with actinic keratosis. Clin Ther 2002; 24: 990-1000.
26. 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: 934-943.
27. Fidler B, Goldberg T,. Ingenol mebutate gel (picato): a novel agent for the treatment of actinic keratoses. PT 2014; 39: 40-46.