Actinic KeratosisSESAMENCT02674048
Metvix Daylight PDT in Actinic Keratosis
An observational study of Actinic Keratosis, run by Galderma R&D at 7 sites in 7 countries.
Trial summary
Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Metvix
- How many people
- 406 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Sep 2015to Nov 2016
- 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 with mild to moderate Actinic Keratosis on the face or scalpe
Who may be able to join
- Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;
Who cannot join
None listed.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp
Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction.
- Conditions
- Actinic Keratosis
- Being tested
- Metvix
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetvixOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of physician satisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall are you satisfied with Metvix DL-PDT?"
Measured: 3 months
Percentage of patient satisfisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall, how satisfied are you with this treatment?".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionNov 2016
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 KeratosisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674048
- Sponsor's protocol ID
- RD.03.SPR.104956
- Acronym
- SESAME
- Status last verified
- Jan 2017
- First submitted
- 16 Dec 2015
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
See JA, Gebauer K, Wu JK, Manoharan S, Kerrouche N, Sullivan J. High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia. Dermatol Ther (Heidelb). 2017 Dec;7(4):525-533. doi: 10.1007/s13555-017-0199-9. Epub 2017 Sep 13.
PubMed 28905294
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp
- ClinicalTrials.gov ID
- NCT02674048
- Acronym / sponsor ID
- SESAME / RD.03.SPR.104956
- Conditions
- Actinic Keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Feb 2016 (estimated)
- 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.
Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction.
Study design
- Observational model
- Other
- 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 with mild to moderate Actinic Keratosis on the face or scalpe
Key inclusion criteria (1 listed)
- Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;
Key exclusion criteria (0 listed)
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 | Other | – |
Primary outcome
Percentage of physician satisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall are you satisfied with Metvix DL-PDT?"
Time frame: 3 months
Percentage of patient satisfisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall, how satisfied are you with this treatment?".
Time frame: 3 months
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 17 Feb 2021.
- Derived from this study: PubMed 28905294See JA, Gebauer K, Wu JK, Manoharan S, Kerrouche N, Sullivan J. High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia. Dermatol Ther (Heidelb). 2017 Dec;7(4):525-533. doi: 10.1007/s13555-017-0199-9. Epub 2017 Sep 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by Galderma R&D at 7 sites in 7 countries.
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 1 inclusion and 0 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, France, Italy, Netherlands, Spain and 2 more countries. 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?
Percentage of physician satisfaction assessed on a 4-point scale from very satisfied to not satisfied with the question "Overall are you satisfied with Metvix DL-PDT?" (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02674048, 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 17 Feb 2021.