Allmedic PDT does not prevent skin cancers

Randomized controlled trial demonstrates no cancer prevention

Abstract: - Dermatologic Surgery April 2014

Background: Development of new skin cancers.

Objective: Does field photodynamic therapy (PDT) of actinic keratoses using a novel preparation of 5-aminolevulonic acid (novel ALA) result in fewer subsequent invasive skin cancers developing on the face of those with previous facial cutaneous malignancy via prospective randomized controlled trial?

Methods & Materials; Intervention patients received two treatments of Novel ALA two weeks apart. Controls were observed. Patients were followed up with biopsy of any suspicious lesions for three years.

Results: The trial was suspended early due to problems with trial governance and the reporting of severe adverse events. 64 patients recruited at that time at one center were monitored. Their average age was 71 and 57% were male. Patients were randomized to intervention (34) and to observation (29). Over the subsequent three years, 13 intervention patients (38%) developed 30 new cutaneous malignancies in the field treated compared with 11 control patients (38%) developing 22 new malignancies. Some intervention patients experienced prolonged adverse events including permanent scarring.

Conclusion: Novel ALA made no difference to the likelihood of new malignancies developing. The risks without benefit of this novel ALA are concerning. Lack of efficacy and safety of novel ALA cannot be extrapolated to other PDT products