Metvix Daylight PDT in Actinic Keratosis (SESAME)

February 16, 2021 updated by: Galderma R&D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

406

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with mild to moderate Actinic Keratosis on the face or scalpe

Description

Inclusion Criteria:

  • Patients to whom Metvix® Daylight-PDT has already been prescribed by their physician, according to the local label;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Collaborators

Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.104956

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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