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Active, Not Recruiting

NCT Number: NCT05976048

Implementation of Actinic Keratosis Guideline Among General Practitioners.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ellen Oyen

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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