Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp.

ABSTRACT:

Background

In actinic keratosis (AK), field cancerization describes areas of skin where multiple visible AK lesions are surrounded by healthy looking skin containing non-visible (subclinical) lesions. As all AK lesions have a risk of progression to cutaneous squamous cell carcinoma, experts advise field-directed treatment. Photodynamic therapy (PDT) is an effective field-directed treatment option for AK; however, long-term efficacy data are still scarce.

Objectives

This publication presents follow-up data of a phase III study evaluating the efficacy and safety of field-directed PDT.

Methods

The study was conducted in seven centres in Germany. For PDT, participants with AKs on the face and scalp (treatment area of 20 cm²) had received up to two field-directe

SUBMITTER: Reinhold U 

PROVIDER: S-EPMC12291023 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature