855
Views
3
CrossRef citations to date
0
Altmetric
Original Research Article

Use of complete clearance for assessing treatment efficacy for 5-fluorouracil interventions in actinic keratoses: how baseline lesion count can impact this outcome

, & ORCID Icon
Article: 1829884 | Received 12 Jun 2020, Accepted 21 Sep 2020, Published online: 09 Oct 2020

References

  • de Berker D, McGregor JM, Mohd Mustapa MF, et al. British Association of Dermatologists’ guidelines for the care of patients with actinic keratosis 2017. Br J Dermatol. 2017;176(1):20–6. .
  • Stockfleth E, Kerl H, Zwingers T, et al. 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(5):1101–1108. .
  • Szeimies RM, Atanasov P, Bissonnette R. Use of lesion response rate in actinic keratosis trials. Dermatol Ther (Heidelb). 2016;6(4):461–464.
  • Traianou A, Ulrich M, Apalla Z, et al. Risk factors for actinic keratosis in eight European centres: a case-control study. Br J Dermatol. 2012;167(Suppl2):36–42. .
  • Dirschka T, Gupta G, Micali G, et al. Real-world approach to actinic keratosis management: practical treatment algorithm for office-based dermatology. J Dermatolog Treat. 2017;28(5):431–442. .
  • Wolf JE Jr., Rigel DS. Understanding efficacy end-points in studies of field-directed therapy for actinic keratosis. Int J Dermatol. 2013;52(9):1063–1070.
  • Fernandez-Figueras MT, Carrato C, Saenz X, et al. Actinic keratosis with atypical basal cells (AK I) is the most common lesion associated with invasive squamous cell carcinoma of the skin. J Eur Acad Dermatol Venereol. 2015;29(5):991–997. .
  • Stockfleth E, von Kiedrowski R, Dominicus R, et al. Efficacy and safety of 5-fluorouracil 0.5%/salicylic acid 10% in the field-directed treatment of actinic keratosis: a phase III, randomized, double-blind, vehicle-controlled trial. Dermatol Ther (Heidelb). 2017;7(1):81–96. .
  • Huyke C, Reuter J, Rodig M, et al. Treatment of actinic keratoses with a novel betulin-based oleogel. A prospective, randomized, comparative pilot study. J Dtsch Dermatol Ges. 2009;7(2):128–133.
  • Skov T, Stockfleth E, Szeimies RM, et al. Efficacy endpoints in clinical trials in actinic keratosis. Dermatol Ther (Heidelb). 2018;8(3):425–433. .
  • Stockfleth E, Ulrich C, Lange-Asschenfeldt B, et al. Treatment of multiple, multiform actinic keratoses on the head with imiquimod 5% cream. Eur J Dermatol. 2009;19(4):355–359. .
  • Dohil MA. Efficacy, safety, and tolerability of 4% 5-fluorouracil cream in a novel patented aqueous cream containing peanut oil once daily compared with 5% 5-fluorouracil cream twice daily: meeting the challenge in the treatment of actinic keratosis. J Drugs Dermatol. 2016;15(10):1218–1224.
  • Krawtchenko N, Roewert-Huber J, Ulrich M, et al. A randomised study of topical 5% imiquimod vs. topical 5-fluorouracil vs. cryosurgery in immunocompetent patients with actinic keratoses: a comparison of clinical and histological outcomes including 1-year follow-up. Br J Dermatol. 2007;157(Suppl 2):34–40. .
  • Weiss J, Menter A, Hevia O, et al. Effective treatment of actinic keratosis with 0.5% fluorouracil cream for 1, 2, or 4 weeks. Cutis. 2002;70(2Suppl):22–29.
  • Pierre Fabre data on file. HD-FUDR-045: A Randomized, Evaluator Blinded, Vehicle Controlled, Parallel Group, Dose Ranging Study of the Safety and Efficacy of 4% 5-FU Cream Versus its Vehicle Cream Versus Efudex in the Treatment of Actinic Keratosis. 2005.
  • Pierre Fabre data on file. HD-FUP3S-049: A Randomized, Double-Blind, Vehicle-Controlled Multi-Center Study of the Safety and Efficacy of 4% 5-FU Cream Versus its Vehicle Cream in the Treatment of Actinic Keratosis. 2007.
  • Pierre Fabre data on file. HD-FUP3B-048: A Randomized, Evaluator Blinded, Vehicle-Controlled Multi-Center Study of the Safety and Efficacy of 4% 5-FU Cream Versus its Vehicle Cream Versus Efudex Cream in the Treatment of Actinic Keratosis. 2007.
  • Reynolds KA, Schlessinger DI, Vasic J, et al. Core outcome set for actinic keratosis clinical trials. JAMA Dermatology. 2020 Jan 15;156(3):326. Epub ahead of print.
  • Foley P, Stockfleth E, Peris K, et al. Adherence to topical therapies in actinic keratosis: a literature review. J Dermatolog Treat. 2016;27(6):538–545. .
  • Norrlid H, Norlin JM, Holmstrup H, et al. Patient-reported outcomes in topical field treatment of actinic keratosis in Swedish and Danish patients. J Dermatological Treat. 2018;29(1):68–73. .
  • Heppt MV, Steeb T, Schmitz L, et al. Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set. Trials. 2019;20(1):589. .