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Completed

NCT Number: NCT05725213

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Vest GmbH

Recklinghausen, 45657, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metvix® 160 mg/g Creme

Drug

Patients are treated with Metvix creme and exposed to artificial daylight

Other names: Methyl-5-aminolevulinate

Primary outcomes

  1. Real-world applicability of the ADL-PDT

    Time frame: 3 months after treatment

    Rate of resolved AK lesions in the focal region

Secondary outcomes

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

    Time frame: 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)

  2. Change in AKASI score over the course of the study

    Time frame: 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)

  3. Change in the number of lesions over the course of the study

    Time frame: 3 months after treatment

    Change in the number of lesions over the course of the study

  4. Query of the type of skin preparation by the investigator

    Time frame: 3 months after treatment

    Query of the type skin preparation by the investigator through questionnaire.

  5. Performance of artificial daylight exposure (artificial daylight system used)

    Time frame: 3 months after treatment

    Investigation which artificial daylight system is used through questionnaire.

  6. Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)

    Time frame: 3 months after treatment

    Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)

  7. Occurrence of local skin irritations or adverse events

    Time frame: 3 months after treatment

    Occurrence of local skin irritations or adverse events

  8. Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator

    Time frame: 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)

  9. Assessment of satisfaction by the patient

    Time frame: 3 months after treatment

    Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied

Sponsors and collaborators

Lead sponsor

Galderma Laboratorium GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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