Daylight photodynamic therapy for prevention of new actinic keratosis and keratinocyte carcinomas in organ transplants. A cryotherapy-controlled randomized clinical trial.
Bernad, I., et al. (2019).Journal of the European Academy of Dermatology & Venereology [record in progress].
Aims
To determine whether repeated treatments of field cancerization with daylight photodynamic therapy (DPDT) are effective in preventing new actinic keratosis (AK) and keratinocyte carcinomas (KC) in organ transplant recipients (OTR).
Interventions
Each patient’s side of the face and/or scalp was randomly allocated to receive field- therapy with DPDT (to treat AK and field cancerization) or lesion-specific treatment with cryotherapy (to treat only AK in isolation, but not field cancerization). The control side was treated with lesion-directed cryotherapy at baseline, at 3, and at 9 months.
Participants
Twenty three 1-year post-organ transplant recipients, with at least 5 AK on each side of the face and/or scalp, were analysed at 3 months; and 21, at 9, 15 and 21 months.
Outcomes
The primary outcome of this study was to determine if there was a difference in the total number of skin lesions (new and persistent AK, and KC) at 21 months after initial treatment. Secondary outcomes included evaluating difference at 3, 9 and 15 months. Time to KC was also measured.
Follow-up
15 and 21 months
CET Conclusions
The RCT compared daylight photodynamic therapy versus cryotherapy to prevent the occurrence of new actinic keratosis (AK) and keratinocyte carcinomas (KC). Adult heart, liver and kidney transplant recipients who were at least 1 year posttransplant and had at least five AKs on each side of the face or scalp were included. The sides of the face or scalp were allocated according to a computer-generated sequence by central randomisation to six sessions of field therapy with DPDT or three sessions of lesion-specific cryotherapy. A blinded outcome assessor evaluated the skin at 3, 9, 15 and 21 months. The sample size calculation showed that 22 patients were needed to ensure a power of 80%. Twenty-four Caucasian patients were included in the study and 3 patients withdrew from the study. At baseline the number of AKs was similar between groups. There were no differences in new AKs and KC at 21 months and not differences in persistent AK at 3, 9 or 15 months. DPDT was better tolerated, patients were more satisfied with DPDT at 21 months and preferred DPDT over cryotherapy. Quality of life scores were improved from baseline to the 21 month follow up but there were no differences between groups. There were no serious adverse events.
Data analysis
Modified intention-to-treat analysis
Trial registration
EudraCT Number: 2015-002663-42