title: Primary prevention of skin dysplasia in renal transplant recipients with photodynamic therapy: a randomized controlled trial.
abstract: Organ transplant recipients (OTRs) are at high risk of developing cutaneous squamous cell carcinoma (SCC); prevention includes early treatment of premalignant actinic keratosis (AK). Photodynamic therapy (PDT) is a noninvasive field therapy that reduces new AKs in patients with existing AK and delays SCC development in mice. We investigated the effect of repeated PDT over 5 years for primary prophylaxis of skin dysplasia. These data represent an interim analysis of an on-going randomized controlled trial. During 2008-2011, 25 renal transplant recipients with clinically normal skin were randomized to split-side PDT of the face, forearm and hand, the contralateral side serving as untreated control. Patients received PDT on inclusion and at 6-monthly intervals for 5 years. Blinded evaluation was performed at each visit. We found that prophylactic PDT significantly delayed onset of AK compared with untreated skin, p = 0.020. At 3-year follow-up, we observed AK in 63% of patients in untreated skin areas compared with 28% of patients in PDT-treated skin, with a total number of cumulated AKs in untreated skin (n = 43) compared with PDT-treated skin (n = 8), p = 0.005. These preliminary data indicate a novel approach to early prevention of skin dysplasia that may reduce morbidity from multiple AKs and SCCs in OTR.
authors.affiliation: Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Togsverd-Bo
authors.affiliation: Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: S H
authors.initials: SH
authors.lastname: Omland
authors.affiliation: Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: H C
authors.initials: HC
authors.lastname: Wulf
authors.affiliation: Department of Nephrology P, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: S S
authors.initials: SS
authors.lastname: Sørensen
authors.affiliation: Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Haedersdal
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D055623:Keratosis, Actinic / Q000188:drug therapy / Q000473:pathology / Q000517:prevention & control*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000379:methods*; D011230:Precancerous Conditions / Q000188:drug therapy / Q000473:pathology* / Q000517:prevention & control; D011300:Preoperative Care / Q000379:methods; D011322:Primary Prevention / Q000379:methods*; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D013997:Time Factors; D066027:Transplant Recipients; D016896:Treatment Outcome
keywords: cancer/malignancy/neoplasia: skin; clinical trial; nonmelanoma