Implementation of Actinic Keratosis Guideline Among General Practitioners.

April 2, 2025 updated by: Maastricht University Medical Center

Implementation of Actinic Keratosis Guideline Among General Practitioners. Retrospective Cohort Study on Prescription Patterns in the Treatment of Actinic Keratosis.

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice. Both dermatologists and general practitioners are increasingly confronted with actinic keratosis, entailing to higher healthcare costs and time burden.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy. Both dermatologists and general practitioners can treat actinic keratosis and 5-fluorouracil cream can also be prescribed by general practitioners.

The objective of this study was to investigate 5-fluorouracil cream prescription trends by general practitioner for the treatment of field changes of actinic keratosis over the years 2016-2021.

Study Type

Observational

Enrollment (Estimated)

1000

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream
Time Frame: Measurement years 2016, 2019 and 2021
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

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Klara Mosterd, prof.dr., Maastricht UMC+

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 (Actual)

March 1, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1313

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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