Implementation of Actinic Keratosis Guideline Among General Practitioners.

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05976048

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

18.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

cutaneous malignancy (suspicion)
immunosuppressive co-medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ellen Oyen	Maastricht		Netherlands

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT05976048

Other Study ID Numbers:

2019-1313

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 9, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maastricht University Medical Center

Additional relevant MeSH terms:

Keratosis, Actinic

Keratosis

Study Results

No Results Posted as of Aug 9, 2023