Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02674048




Registration number
NCT02674048
Ethics application status
Date submitted
16/12/2015
Date registered
4/02/2016
Date last updated
17/02/2021

Titles & IDs
Public title
Metvix Daylight PDT in Actinic Keratosis
Scientific 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
Secondary ID [1] 0 0
RD.03.SPR.104956
Universal Trial Number (UTN)
Trial acronym
SESAME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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?"
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
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?".
Timepoint [2] 0 0
3 months

Eligibility
Key inclusion criteria
* Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
406
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
See Jo-Ann - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Pontoise
Country [2] 0 0
Italy
State/province [2] 0 0
L'Aquila
Country [3] 0 0
Netherlands
State/province [3] 0 0
Alkmaar
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid
Country [5] 0 0
Switzerland
State/province [5] 0 0
Bern
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galderma R&D
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02674048
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02674048