NCT05976048

Brief Summary

This study investigates 5-fluorouracil cream prescription trends by general practitioners for the treatment of field changes of actinic keratosis over the years 2016-2021. The aim is to analyse whether the publication of the multidisciplinary guideline on suspect skin lesions for general practitioners in 2017 has made an impact in the prescribing behaviour of general practitioners.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

July 20, 2023

Last Update Submit

April 2, 2025

Conditions

Actinic Keratoses

Keywords

actinic keratosisgeneral physician5-fluorouracil creamgeneral practitioner

Outcome Measures

Primary Outcomes (1)

  • Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream

    Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream by general practitioners for the diagnosis actinic keratosis, measured from the Research Network Family Medicine Maastricht database between 2016 - 2021. The Research Network Family Medicine is a registration database with information about the affiliated general practices.

    Measurement years 2016, 2019 and 2021

Eligibility Criteria

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

Data of patients with actinic keratosis in the general practitioners extracted from the Research network family medicine (RNFM) Maastricht database between 2016 - 2021.

You may qualify if:

  • age \>18 years
  • diagnosis actinic keratosis (clinical diagnosed or by biopsy)

You may not qualify if:

  • cutaneous malignancy (suspicion)
  • immunosuppressive co-medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ellen Oyen

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Klara Mosterd, prof.dr.

    Maastricht UMC+

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 4, 2023

Study Start

March 1, 2020

Primary Completion

September 1, 2022

Study Completion

December 1, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

NL(1)