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)

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: Metvix® 160 mg/g Creme

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 Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

• Study Contact: Name: Matthias Brückner, Dr.; Phone Number: +49 211 58601 4375; Email: matthias.brueckner@galderma.com

Study Locations

• Germany
  • Recklinghausen, Germany, 45657
    • Klinikum Vest GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients selected from pool of dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world applicability of the ADL-PDT	Rate of resolved AK lesions in the focal region	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in AKASI score over the course of the study	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
Assessment of satisfaction by the patient	Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied	3 months after treatment
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

Collaborators and Investigators

• Sponsor: Galderma Laboratorium GmbH
• Investigators: Principal Investigator: Rolf-Markus Szeimies, Prof. Dr., KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid; Methyl 5-aminolevulinate
• Other Study ID Numbers: ArtLight

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No