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Clinical trial

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

ID
Name
ArtLight
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.
Trial arms
Trial start
2022-11-01
Estimated PCD
2023-10-30
Trial end
2023-10-30
Status
Completed
Treatment
Metvix® 160 mg/g Creme
Patients are treated with Metvix creme and exposed to artificial daylight
Other names:
Methyl-5-aminolevulinate
Size
224
Primary endpoint
Real-world applicability of the ADL-PDT
3 months after treatment
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 224, 'type': 'ACTUAL'}}
Updated at
2024-02-23

1 organization

1 product

1 indication

Organization
Galderma Laboratorium
Product
Metvix
Indication
Actinic Keratosis