Pretreatment with topical 5-fluorouracil before daylight photodynamic therapy for actinic keratoses – a randomized controlled study
Actinic keratoses are very common premalignant lesion in sun exposed skin.
5-Fluorouracil cream and photodynamic therapy are effective treatment for especially thin actinic keratosis and more effective treatments are needed for thicker lesions. Combination treatment with 5-fluorouracil cream and photodynamic therapy may enhance the efficacy and introduce an easy and tolerable treatment option for these very common lesions.
The objective of the study is to investigate if pre-treatment with 5-fluorouracil cream can enhance the efficacy of daylight photodynamic therapy of actinic keratoses in the face and scalp. Patients with multiple actinic keratoses will be included in the study and serve as their own control due to the split-face design. To symmetrical areas are marked and one area is randomized 5-fluorouracil cream for 7 days. Both treatment areas are then treated with daylight photodynamic therapy either outdoor or indoor using daylight lamps. The efficacy of the treatment is evaluated after 3, 6 and 12 months.
Photo: Nis Kentorp
Researcher
Consultant dermatologist Stine Regin Wiegell, PhD, MDSc (Bispebjerg Hospital)
Project supervisors
Professor Peter Bjering
Professor Merete Hædersdal
Project period
Year: 2021 - 2024
Project collaborators
Professor Uwe Paasch, Leipzig German Medical Engineering, Erlangen, Germany (sponsoreret Dagslys-lamper)
Financing
Department of Dermatology, Bispebjerg Hospital
SkinCenter Mølholm Private Hospital
Danish Research Center for Skin cancer
Selected publications
Wiegell SR, Wulf HC, Szeimies R-M et al. Daylight photodynamic therapy for actinic keratosis: an international consensus. JEADV 2012; 26:673-9
Wiegell SR, Fabricius S, Gniadecka M et al. Daylight-mediated photodynamic therapy of moderate to thick actinic keratoses of the face and scalp: a randomized multicentre study. Br J Dermatol 2012; 166:1327-32
Nissen CV, Heerfordt I, Wiegell SR al. Pretreatment with 5-Fluorouracil cream enhances the efficacy of daylight-mediated photodynamic therapy for actinic keratosis. Acta Derm Venereol 2017; 97:617-21.
Maytin EV, Anand S, Riha M et al. 5-Fluorouracil enhances protoporphyrin IX accumulation and lesion clearance during photodynamic therapy of actinic keratoses: a mechanism-based clinical trial. Clin Cancer Res 2018; 24:3026-35.
Pei S, Kaminska ECN, Tsoukas MM. Treatment of actinic keratoses: a randomized split-site approach comparison of sequential 5-fluorouracil and 5-aminolevulinic acid photodynamic therapy to 5-aminolevulinic acid photodynamic monotherapy. Dermatol Surg 2017: 43: 1170-1175.