Implementation of Actinic Keratosis Guideline Among General Practitioners.

Active, not recruiting

• Conditions: Actinic Keratoses

• Registration Number: NCT05976048
• Lead Sponsor: Maastricht University Medical Center

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.

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 Timeline

• Study Start: 2020-03-01
• Primary Completion: 2022-09-01
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage (%) of longitudinal changes in prescriptions of 5-fluorouracil cream	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.

Trial Locations

Locations (1)

Ellen Oyen; 🇳🇱 Maastricht, Netherlands