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

Actinic Keratoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725213
• Other study ID #: ArtLight
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Galderma Laboratorium GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Metvix® 160 mg/g Creme
Patients are treated with Metvix creme and exposed to artificial daylight

Locations

Country	Name	City	State
Germany	Klinikum Vest GmbH	Recklinghausen

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Laboratorium GmbH

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world applicability of the ADL-PDT	Rate of resolved AK lesions in the focal region	3 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Performance of artificial daylight exposure (artificial daylight system used)	Investigation which artificial daylight system is used through questionnaire.	3 months after treatment
Secondary	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
Secondary	Occurrence of local skin irritations or adverse events	Occurrence of local skin irritations or adverse events	3 months after treatment
Secondary	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
Secondary	Assessment of satisfaction by the patient	Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied	3 months after treatment