NCT02674048

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
7 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 17, 2021

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

December 16, 2015

Last Update Submit

February 16, 2021

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

MetvixOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

See Jo-Ann

Sydney, New South Wales, 2000, Australia

Location

France

Pontoise, France

Location

Italy

L’Aquila, Italy

Location

Alkmaar

Alkmaar, Netherlands

Location

Madrid

Madrid, Spain

Location

Bern

Bern, Switzerland

Location

Manchester

Manchester, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28905294DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

February 4, 2016

Study Start

September 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

February 17, 2021

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)AU(1)ES(1)IT(1)FR(1)NL(1)GB(1)