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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

NCT00304239

Actinic Keratosis

COMPLETED PHASE3

Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

NCT01475071

Actinic Keratoses

COMPLETED PHASE3

Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer

NCT00472459

Actinic Keratosis Warts Basal Cell Carcinoma +2 more

COMPLETED PHASE3

Actinic Keratoses Treatment With Metvix® in Combination With Light

NCT02373371

Actinic Keratoses

COMPLETED PHASE3

Metvix Daylight PDT in Actinic Keratosis

NCT02674048

Actinic Keratosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Actinic Keratoses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metvix® 160 mg/g Creme

Patients are treated with Metvix creme and exposed to artificial daylight

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Methyl-5-aminolevulinate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No