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

Completed

• Conditions: Actinic Keratoses

• Registration Number: NCT05725213
• Lead Sponsor: Galderma Laboratorium GmbH

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world applicability of the ADL-PDT	3 months after treatment	Rate of resolved AK lesions in the focal region

Secondary Outcome Measures

Name	Time	Method
Change in skin quality over the course of the study overall and in the focus region	3 months after treatment	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)
Change in AKASI score over the course of the study	3 months after treatment	Change in AKASI score over the course of the study Scale: 0 (no AK) to 18 (AK with highest level of severity)
Performance of artificial daylight exposure (artificial daylight system used)	3 months after treatment	Investigation which artificial daylight system is used through questionnaire.
Occurrence of local skin irritations or adverse events	3 months after treatment	Occurrence of local skin irritations or adverse events
Assessment of satisfaction by the patient	3 months after treatment	Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied
Change in the number of lesions over the course of the study	3 months after treatment	Change in the number of lesions over the course of the study
Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)	3 months after treatment	Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)
Query of the type of skin preparation by the investigator	3 months after treatment	Query of the type skin preparation by the investigator through questionnaire.
Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator	3 months after treatment	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)

Trial Locations

Locations (1)

Klinikum Vest GmbH; 🇩🇪 Recklinghausen, Germany