ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight)

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Metvix® 160 mg/g Creme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent to participate in the study Age ≥18 years Thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face or scalp (Olsen grade 1 or Olsen grade 2) The decision to undergo ADL-PDT with Metvix® was made independently of this study No contraindication (according to the SmPC) Exclusion Criteria: Hypersensitivity to the active substance or to one of the other ingredients listed in section 6.1 of the SmPC or other ingredients, including peanut oil, peanut or soy. Morpheaform basal cell carcinoma Porphyria Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metvix® 160 mg/g Creme|Patients are treated with Metvix creme and exposed to artificial daylight|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world applicability of the ADL-PDT | Rate of resolved AK lesions in the focal region | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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. | 3 months after treatment | 
| Performance of artificial daylight exposure (artificial daylight system used) | Investigation which artificial daylight system is used through questionnaire. | 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) | 3 months after treatment | 
| Occurrence of local skin irritations or adverse events | Occurrence of local skin irritations or adverse events | 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) | 3 months after treatment | 
| Assessment of satisfaction by the patient | Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied | 3 months after treatment |