NCT05725213

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 224 (actual)
• Sponsor: Galderma Laboratorium GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Metvix® 160 mg/g Creme	Patients are treated with Metvix creme and exposed to artificial daylight

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2023-02-13
• Last updated: 2024-02-23

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study