Clinical trial NCT05725213: ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis
Official title: Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratoses
Lead sponsor: Galderma Laboratorium GmbH
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Real-world applicability of the ADL-PDT
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Change in skin quality over the course of the study overall and in the focus region
timeFrame: 3 months after treatment
measure: Change in AKASI score over the course of the study
timeFrame: 3 months after treatment
measure: Change in the number of lesions over the course of the study
timeFrame: 3 months after treatment
measure: Query of the type of skin preparation by the investigator
timeFrame: 3 months after treatment
measure: Performance of artificial daylight exposure (artificial daylight system used)
timeFrame: 3 months after treatment
measure: Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)
timeFrame: 3 months after treatment
measure: Occurrence of local skin irritations or adverse events
timeFrame: 3 months after treatment
measure: Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator
timeFrame: 3 months after treatment
measure: Assessment of satisfaction by the patient
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Recklinghausen
country: Germany
facility: Klinikum Vest GmbH
Study officials:
affiliation: KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen
name: Rolf-Markus Szeimies, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.