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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metvix® 160 mg/g Creme | Drug | Patients are treated with Metvix creme and exposed to artificial daylight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world applicability of the ADL-PDT | Rate of resolved AK lesions in the focal region | 3 months after treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients selected from pool of dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses.
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| Name | Affiliation | Role |
|---|---|---|
| Rolf-Markus Szeimies, Prof. Dr. | KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Vest GmbH | Recklinghausen | 45657 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33313936 | Background | Karrer S, Szeimies RM, Philipp-Dormston WG, Gerber PA, Prager W, Datz E, Zeman F, Muller K, Koller M. Repetitive Daylight Photodynamic Therapy versus Cryosurgery for Prevention of Actinic Keratoses in Photodamaged Facial Skin: A Prospective, Randomized Controlled Multicentre Two-armed Study. Acta Derm Venereol. 2021 Jan 4;101(1):adv00355. doi: 10.2340/00015555-3717. |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |