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

NCT05725213 | Completed FDA Drug

• 1 other identifier: ArtLight
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Real-world applicability of the ADL-PDT

  Rate of resolved AK lesions in the focal region

  3 months after treatment

Secondary Outcomes (9)

• Change in skin quality over the course of the study overall and in the focus region

  3 months after treatment

• Change in AKASI score over the course of the study

  3 months after treatment

• 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

  3 months after treatment

• Performance of artificial daylight exposure (artificial daylight system used)

  3 months after treatment

Interventions

Metvix® 160 mg/g Creme DRUG

Patients are treated with Metvix creme and exposed to artificial daylight

Also known as: Methyl-5-aminolevulinate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma Laboratorium GmbH: lead

Study Sites (1)

Klinikum Vest GmbH

Recklinghausen, 45657, Germany

Location

Related Publications (1)

• 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.

  PMID: 33313936 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rolf-Markus Szeimies, Prof. Dr.

  KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 13, 2023
• Study Start: November 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)