Combination of ablative fractional laser and daylight mediated photodynamic therapy for actinic keratosis in organ transplant recipients - a randomized controlled trial.
Togsverd-Bo K, Lei U, et al.British Journal of Dermatology [record in progress].
Aims
To investigate the efficacy of ablative fractional laser (AFL) assisted daylight photodynamic therapy (PDT) versus daylight PDT (dPDT), conventional PDT (cPTD) and AFL alone as treatment for actinic keratosis (AK) in organ transplant recipients.
Interventions
Patients were administered with a single field directed treatment of AFL-dPDT, dPDT with MAL (Metrix cream)applied for 2.5 hours without occlusion during daylight exposure, cPDT MAL occluded for 3 hours followed by red light (630nm) and AFL administered with a 2940nm ablative fractional laser at 2.3mJ/pulse, 1.15W, two stacked, 50 microsecond pulse duration and 2.4% density.
Participants
16 organ transplant recipients with a solid graft and clinical diagnosis of AK.
Outcomes
The primary outcome was complete lesion response at one and three months post-treatment. Secondary outcomes were pain during AFL and light exposure, short and long-term skin reactions, investigator and patient evaluated cosmetic outcome and 5-ALA-induced protoporphyrin (PpIX) fluorescence.
Follow-up
One and three months.
CET Conclusions
In this carefully planned evaluation blinded study the authors have compared ablative fractional laser therapy (AFL) and assisted photodynamic therapy (AFL-dPDT) with daylight PDT, conventional PDT and AFL alone in areas of skin that had precancerous field changes. There was a significant reduction in actinic keratosis as judged by complete remission with AFL assisted PDT compared to daylight PDT, conventional PDT and AFL alone as a field treatment of actinic keratosis. The data are convincing but what we don’t know is if conventional treatments with 5 fluorouracil would produce a similar result. In summary this is an important study in what is a major problem in all organ transplant recipients with long surviving grafts, remembering that on occasions metastasis of squamous cell skin cancers can result in death.
Data analysis
Per protocol analysis
Trial registration
EudraCT 2012 – 002233-11