ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- Real-world applicability of the ADL-PDT [3 months after treatment]
Rate of resolved AK lesions in the focal region
Secondary Outcome Measures
- Change in skin quality over the course of the study overall and in the focus region [3 months after treatment]
Change in skin quality over the course of the study overall and in the focus region (according to Karrer et al. doi: 10.2340/00015555-3717 Acta Derm Venereol 2021; 101: adv00355) through 5 scales questionnaire. Scale from 0 (none) to 5 (strong)
- Change in AKASI score over the course of the study [3 months after treatment]
Change in AKASI score over the course of the study
- Change in the number of lesions over the course of the study [3 months after treatment]
Change in the number of lesions over the course of the study
- Query of the type of skin preparation by the investigator [3 months after treatment]
Query of the type skin preparation by the investigator through questionnaire.
- Performance of artificial daylight exposure (artificial daylight system used) [3 months after treatment]
Investigation which artificial daylight system is used through questionnaire.
- Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe) [3 months after treatment]
Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)
- Occurrence of local skin irritations or adverse events [3 months after treatment]
Occurrence of local skin irritations or adverse events
- Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator [3 months after treatment]
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)
- Assessment of satisfaction by the patient [3 months after treatment]
Assessment of satisfaction by the patient through questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent to participate in the study
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Age ≥18 years
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Thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face or scalp (Olsen grade 1 or Olsen grade 2)
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The decision to undergo ADL-PDT with Metvix® was made independently of this study
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No contraindication (according to the SmPC)
Exclusion Criteria:
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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.
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Morphaeaform basal cell carcinoma
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Porphyria
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Vest GmbH | Recklinghausen | Germany | 45657 |
Sponsors and Collaborators
- Galderma Laboratorium GmbH
Investigators
- Principal Investigator: Rolf-Markus Szeimies, Prof. Dr., KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ArtLight