The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions.
The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions. Furthermore, this NIS will document the efficacy, satisfaction, safety and tolerability of ADL-PDT with Metvix® in routine use according to the label. The observational study is designed as a multicenter study, covering all parts of Germany. Participating investigators are dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses. The observation time per patient will comprise up to 6 months, including up to 4 visits.
Study Type
OBSERVATIONAL
Enrollment
224
Patients are treated with Metvix creme and exposed to artificial daylight
Klinikum Vest GmbH
Recklinghausen, Germany
Real-world applicability of the ADL-PDT
Rate of resolved AK lesions in the focal region
Time frame: 3 months after treatment
Change in skin quality over the course of the study overall and in the focus region
Change in skin quality over the course of the study overall and in the focus region through 5 scales questionnaire. Scale from 0 (none) to 5 (strong)
Time frame: 3 months after treatment
Change in AKASI score over the course of the study
Change in AKASI score over the course of the study Scale: 0 (no AK) to 18 (AK with highest level of severity)
Time frame: 3 months after treatment
Change in the number of lesions over the course of the study
Change in the number of lesions over the course of the study
Time frame: 3 months after treatment
Query of the type of skin preparation by the investigator
Query of the type skin preparation by the investigator through questionnaire.
Time frame: 3 months after treatment
Performance of artificial daylight exposure (artificial daylight system used)
Investigation which artificial daylight system is used through questionnaire.
Time frame: 3 months after treatment
Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)
Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)
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Time frame: 3 months after treatment
Occurrence of local skin irritations or adverse events
Occurrence of local skin irritations or adverse events
Time frame: 3 months after treatment
Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator
Overall assessment (by investigator) of efficacy, tolerability, adherence, cosmetics through 5 scales questionnaire. Scale: 1 (very good) to 5 (very unsatisfied, or no effect at all)
Time frame: 3 months after treatment
Assessment of satisfaction by the patient
Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied
Time frame: 3 months after treatment