Split-face-study using two different light sources for topical PDT of actinic keratoses:non-inferiority of the LED system

Abstract

Background: Photodynamic therapy (PDT) with 5-amino-4-oxo-pentanoate (methylaminolevulinate, MAL) is an effective and safe treatment option for actinic keratoses. Light-emitting diodes (LED) are suitable light sources for topical PDT. To evaluate the efficacy, painfulness, patient satisfaction and cosmesis of LED-based PDT a prospective, randomized and controlled split-face study was performed.

Methods: Topical ALA-PDT was administered to 17 patients whose actinic ker-atoses (n = 131) were symmetrically distributed and suitable for a two-side comparison. After incubation with MAL (16%), irradiation was performed with the incoherent lamp (160 mW cm(-2); 100 J cm(-2), PDT 1200L, Waldmann Medizintechnik, Villingen-Schwenningen, Germany) on one side and the LED system (120 mW cm(-2); 40 J cm(-2), LEDA, WaveLight AG, Erlangen, Germany) on the other side. The patients were followed by re-evaluation up to 6 months.

Results: Six months following treatment there was no significant difference between the infiltration and keratosis scores in both treatment regimes (p = 0.812). The remission rate was 78.5% (LED system) vs.80.3% (incoherent lamp). There was no significant difference between both light sources regarding the pain during therapy (p = 0.988). There was no significant difference between both treatment regimes regarding patient satisfaction (p = 1).

Conclusions: LEDA-based MAL-PDT is an effective alternative for the treatment of atinic keratoses. The remission rates and cosmetic results are not inferior to PDT using incoherent light systems. Both treatment regimes are similarly painful.