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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