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NCT05976048 Clinical Trial

Implementation of Actinic Keratosis Guideline Among General Practitioners.

Actinic Keratoses Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05976048
Other study ID # 2019-1313
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date September 2024

Study information
Verified date August 2023
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date September 2024
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 years - diagnosis actinic keratosis (clinical diagnosed or by biopsy) Exclusion Criteria: - cutaneous malignancy (suspicion) - immunosuppressive co-medication.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Ellen Oyen Maastricht

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03575780 - Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis Phase 1
Completed NCT04085367 - Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face Phase 3
Completed NCT05937529 - Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis N/A
Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
Completed NCT01354717 - Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo Phase 3
Completed NCT00742391 - A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations Phase 3
Completed NCT03285477 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp Phase 3
Suspended NCT03963102 - Duration of Ameluz Application in Acral Actinic Keratoses Response Phase 4
Not yet recruiting NCT06026358 - Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Phase 4
Completed NCT02622594 - Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times Phase 4
Completed NCT00774787 - Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses Phase 4
Completed NCT00786994 - The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses Phase 2
Completed NCT00544258 - Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005 Phase 1
Completed NCT04024579 - Treatment of Actinic Keratosis With 5% KOH Solution
Completed NCT04843553 - Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients Early Phase 1
Completed NCT03315286 - Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure N/A
Completed NCT03279328 - Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents Phase 4
Completed NCT02062853 - Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video N/A
Terminated NCT01532453 - Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients Phase 3