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

Abstract

Background The efficacy and safety of methyl aminolevulinate daylight photodynamic therapy (MAL DL-PDT) for actinic keratosis (AK) treatment has previously been demonstrated in several studies.Objective To evaluate patient-reported outcomes, effectiveness and tolerability of patient self-applied MAL DL-PDT. Patients and methodsAn open study was conducted in Germany in patients with thin or non-hyperkeratotic and non-pigmented AK. At baseline, the investigator delimited the target anatomical area and skin preparation was discretionary. On day 1, the patient performed MAL DL-PDT at home, in accordance with instructions (after applying sunscreen and skin preparation by abrasive pad). Patient questionnaires were completed on day 1 and 3 months post-treatment.Effectiveness was assessed by investigator at 3 months. Pain and adverse events (AE) were recorded.Results Patients (n = 50) were mostly elderly (mean age: 73.4 years) men (86%). After treatment on day 1, 94% of patients were overall satisfied or very satisfied with the treatment and 98% found the instructions convenient. At 3 months, most patients were satisfied or very satisfied with treatment effectiveness (88%) and aspect of their skin (80%). At 3 months, 62% of overall lesions were completely clear. The main related AEs were mild and expected (erythema, procedural pain and skin burning sensation).Conclusions Patient self-application of MAL DL-PDT resulted in high levels of patient satisfaction, effectiveness and tolerability.

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

“…In an non‐sponsored randomized comparison trial, DL ALA‐PDT was more effective than DL MAL‐PDT in the per‐patient half‐face analysis of clearance (79.7% vs. 73.5%) . In an evaluation of patient self‐application of DL MAL‐PDT, there was high patient satisfaction and at 3 months, with 62% of treated AK were clear …”

“…Alternative methods of delivering light equivalent to daylight, but avoiding the limitations of climate considerations, are emerging, including simple use of a glasshouse and attempting to simulate daylight indoors . The potential to deliver daylight MAL‐PDT at home has demonstrated high levels of patient satisfaction, effectiveness and tolerability …”

Daylight photodynamic therapy of actinic keratosis without curettage is as effective as with curettage: a randomized clinical trial

“…From a previous study, we know that patients are capable of following instructions regarding the timing and duration of daylight exposure at home in their own garden or balcony, without compromising treatment effect . A recent study has investigated daylight PDT where all three components: the pretreatment, MAL application, and daylight exposure were handled by the patients themselves at home, a few days after having had pretreatment of various kinds in the clinic . Overall, the patients were very satisfied with the home‐based treatment.…”

“…Overall, the patients were very satisfied with the home‐based treatment. The study had no control group and consequently, it is not known whether this treatment regimen provides full treatment effect . The next step will be to investigate if patients can apply MAL properly on relevant areas when performing daylight PDT at home, without compromising the treatment effect.…”

Daylight photodynamic therapy: patient willingness to undertake home treatment

“…Commonly, skin surface preparation is performed in a dermatology clinic prior to dPDT. However, a recent German study by Karrer and colleagues investigated dPDT as a patient‐applied home‐delivered treatment for face and scalp AK and reported that patients who undertook this self‐administered treatment had high levels of efficacy, tolerance and patient satisfaction …”