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

Galderma

Status: Completed

Conditions: Actinic Keratoses

Treatments: Drug: Metvix® 160 mg/g Creme

Study type: Observational

Funder types: Industry

Identifiers

NCT05725213

ArtLight

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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