Actinic KeratosesNCT05725213
ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis
An observational study of Actinic Keratoses, run by Galderma Laboratorium GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Metvix® 160 mg/g Creme
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected from pool of dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight)
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.
Read the 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.
- Conditions
- Actinic Keratoses
- Being tested
- Metvix® 160 mg/g Creme
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metvix® 160 mg/g CremeDrug
Also called Methyl-5-aminolevulinate
Patients are treated with Metvix creme and exposed to artificial daylight
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world applicability of the ADL-PDT
Rate of resolved AK lesions in the focal region
Measured: 3 months after treatment
Secondary outcomes (9)
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)
Measured: 3 months after treatment
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)
Measured: 3 months after treatment
Change in the number of lesions over the course of the study
Change in the number of lesions over the course of the study
Measured: 3 months after treatment
Query of the type of skin preparation by the investigator
Query of the type skin preparation by the investigator through questionnaire.
Measured: 3 months after treatment
Performance of artificial daylight exposure (artificial daylight system used)
Investigation which artificial daylight system is used through questionnaire.
Measured: 3 months after treatment
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)
Measured: 3 months after treatment
Occurrence of local skin irritations or adverse events
Occurrence of local skin irritations or adverse events
Measured: 3 months after treatment
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)
Measured: 3 months after treatment
Assessment of satisfaction by the patient
Assessment of satisfaction by the patient through questionnaire Scale: Very satisfied to very dissatisfied
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Nov 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma Laboratorium GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolf-Markus Szeimies, Prof. Dr., Principal investigator, KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725213
- Sponsor's protocol ID
- ArtLight
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33313936
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight)
- ClinicalTrials.gov ID
- NCT05725213
- Acronym / sponsor ID
- ArtLight
- Conditions
- Actinic Keratoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Galderma Laboratorium GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected from pool of dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metvix® 160 mg/g CremeAlso: Methyl-5-aminolevulinatePatients are treated with Metvix creme and exposed to artificial daylight | Drug | – |
Primary outcome
Real-world applicability of the ADL-PDT
Time frame: 3 months after treatment
Rate of resolved AK lesions in the focal region
9 secondary outcomes
Change in skin quality over the course of the study overall and in the focus region
Time frame: 3 months after treatment
Change in AKASI score over the course of the study
Time frame: 3 months after treatment
Change in the number of lesions over the course of the study
Time frame: 3 months after treatment
Query of the type of skin preparation by the investigator
Time frame: 3 months after treatment
Performance of artificial daylight exposure (artificial daylight system used)
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)
Time frame: 3 months after treatment
Occurrence of local skin irritations or adverse events
Time frame: 3 months after treatment
Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator
Time frame: 3 months after treatment
Assessment of satisfaction by the patient
Time frame: 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 33313936Karrer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf-Markus Szeimies, Prof. Dr. principal investigator
KLINIKUM VEST GMBH - Knappschaftskrankenhaus Recklinghausen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratoses, run by Galderma Laboratorium GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world applicability of the ADL-PDT (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05725213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.