Patient and physician satisfaction in an observational study with methyl aminolevulinate daylight photodynamic therapy in the treatment of multiple actinic keratoses of the face and scalp in six European countries

Abstract

BackgroundGuidelines recommend treating actinic keratoses (AKs) as they are recognized as precursors of invasive squamous cell carcinoma.ObjectiveThe objective of this study was to collect real‐world clinical data on the use of methyl aminolevulinate daylight photodynamic therapy (MAL DL‐PDT) for the treatment of face and scalp AK in Europe.MethodsA prospective, multicenter, non‐interventional study was conducted in six European countries in patients receiving a single treatment of MAL DL‐PDT for face and/or scalp AK. Patient‐reported outcomes were assessed by patient questionnaires at baseline and at 3 months after treatment, efficacy was assessed at 3 months using a 6‐point global improvement scale, and adverse events (AE) were recorded at each visit.ResultsOverall, 325 patients were enrolled from 52 investigational centres, 314 of whom attended the 3‐month visit. Most patients had multiple lesions (58.4% had >10 lesions) with lesions mainly located on the scalp (60.0%) and/or forehead (54.2%). AKs were predominantly grade I (39.4%) or grade II (33.2%), and 10.5% of patients had grade III lesions. The proportions of patients and physicians that were overall satisfied to very satisfied with the MAL DL‐PDT treatment were 80.4% and 90.3%, respectively. The vast majority of patients (90.0%) would consider using MAL DL‐PDT again if needed. Physician‐assessed efficacy at 3 months was at least much improved in 83.5% of patients, with 45.9% of patients requiring no retreatment. Related AEs were reported in 15% of patients.ConclusionUse of MAL DL‐PDT for multiple face and/or scalp AKs resulted in high levels of patient and physician satisfaction in clinical practice in Europe, reflecting the good efficacy and high tolerability of this convenient procedure.

European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications – actinic keratoses, Bowen's disease and basal cell carcinomas

“…Both high efficacy and patient satisfaction were demonstrated in a further multicentre study conducted over six European countries, in 325 patients receiving a single treatment of DL MAL-PDT for face and/or scalp AK, demonstrated efficacy at 3 months was at least much improved in 83.5% of patients, with 45.9% of patients requiring no retreatment. 78 DL ALA-PDT using nanoemulsion ALA has at least as effective as DL MAL-PDT in treating mild and moderate AK. In a randomized split-face trial, 13 patients with 177 grade I-III AK, DL ALA-PDT cleared 85% of AK compared with 74% treated by MAL.…”

“…Daylight PDT was virtually pain free in comparison with conventional PDT and was as effective whether performed in sun or cloudy conditions. Both high efficacy and patient satisfaction were demonstrated in a further multicentre study conducted over six European countries, in 325 patients receiving a single treatment of DL MAL‐PDT for face and/or scalp AK, demonstrated efficacy at 3 months was at least much improved in 83.5% of patients, with 45.9% of patients requiring no retreatment …”

Methyl aminolevulinate daylight photodynamic therapy applied at home for non‐hyperkeratotic actinic keratosis of the face or scalp: an open, interventional study conducted in Germany

“…However, the PRO, effectiveness and safety results obtained were similar to those of a randomized controlled trial 10 and a large non-interventional study conducted in six European countries in 325 patients receiving a single treatment of MAL DL-PDT for face and/or scalp AK. 14…”

“…13 Efficacy and safety of methyl aminolevulinate daylight photodynamic therapy (MAL DL-PDT) for AK treatment has previously been demonstrated in several studies. 9,10,14,15 The objective of this open study was to evaluate patientreported outcomes (PRO), effectiveness and tolerability of MAL DL-PDT when applied at home for the field-directed treatment of thin or non-hyperkeratotic and non-pigmented multiple AK on the face or scalp.…”

Early and Late Onset Side Effects of Photodynamic Therapy

“…The constant and slow dynamics of ROS production is probably the mechanism through which Daylight PDT (DL-PDT) is quite less painful respect to conventional PDT, with increased patient tolerance and satisfaction. Compared to conventional PDT, pain intensity during DL-PDT is significantly lower, probably due to continuous production and photoactivation of small amounts of PpIX, with decreased local concentration of ROS and, consequently, reduced stimulation of nerve endings [ 40 , 41 ]. Other important factors influencing pain are lesion type, location and treatment area size.…”