SESAME: Metvix Daylight PDT in Actinic Keratosis
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT02674048
Collaborator
Parexel (Industry)
406
7
14
58
4.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
406 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Study Start Date
:
Sep 1, 2015
Actual Primary Completion Date
:
Oct 1, 2016
Actual Study Completion Date
:
Nov 1, 2016
Outcome Measures
Primary Outcome Measures
- 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?" [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?". [3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | See Jo-Ann | Sydney | New South Wales | Australia | 2000 |
| 2 | France | Pontoise | France | ||
| 3 | Italy | L'Aquila | Italy | ||
| 4 | Alkmaar | Alkmaar | Netherlands | ||
| 5 | Madrid | Madrid | Spain | ||
| 6 | Bern | Bern | Switzerland | ||
| 7 | Manchester | Manchester | United Kingdom |
Sponsors and Collaborators
- Galderma R&D
- Parexel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT02674048
Other Study ID Numbers:
- RD.03.SPR.104956
First Posted:
Feb 4, 2016
Last Update Posted:
Feb 17, 2021
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms: