Trial Title:
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
NCT ID:
NCT06499415
Condition:
Actinic Keratoses
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Fluorouracil
Calcipotriene
Conditions: Keywords:
5-Fluorouracil
Calcipotriol
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
The investigator, who is also a physician and will evaluate treatment effect, is blinded
to the allocated treatment
Intervention:
Intervention type:
Drug
Intervention name:
5FU-Calcipotriol
Description:
topical 5FU-CAL, twice daily, during 4 or 6 consecutive days, depending on the treatment
location
Arm group label:
topical 5FU-CAL, twice daily, during 4 or 6 consecutive days
Intervention type:
Drug
Intervention name:
5-FU 50 MG/ML Topical Cream
Description:
topical 5FU, twice daily, 7 days a week, during 4 weeks
Arm group label:
topical 5FU, twice daily, 7 days a week, during 4 weeks
Summary:
5-Fluorouracil (5FU) is proven to be the most effective therapy in field directed
treatment for AK, with Jansen et al. reporting a 1-year probability of treatment success
of 74.7%. However, treatment with 5FU is associated with side effects, like erythema,
itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily
application for four weeks. This long treatment duration in combination with side-effects
and overall lifestyle adjustments during treatment can be the reason for poor adherence
and premature termination, and it can also lead to future refusal of 5FU therapy.
Therefore, room for improvement lies in increasing the tolerability, in terms of side
effects or treatment duration, while maintaining the efficacy of 5FU in the treatment of
AK.
Addition therapy, which can shorten the duration of treatment, might be the key to
success. Calcipotriol (CAL) enhances thymic stromal lymphopoietin (TSLP), an
epithelium-derived cytokine, which promotes antitumor immunity. Therefore, it is known to
have a synergistic effect when combined with 5FU in the treatment of AK. This suggests
that short-term treatment with 5FU-CAL is effective and provides the opportunity to
shorten duration of treatment, thereby improving tolerability of treatment and full
adherence to the treatment regimen.
However, no study compared 5FU-CAL combination therapy with standard 5FU treatment for a
duration of 28 days. This study aims to evaluate whether a short course of combination
therapy with 5FU-CAL is non-inferior to a full course of 5FU monotherapy with respect to
the 1-year probability of treatment success.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults above 18 years of age
- Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more
area(s):
- Face, ears, (balding) scalp
- Neck/Shawl area, including the sun-exposed chest area
- Upper extremities
- Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2
- AK Olsen grade I-III
Exclusion Criteria:
- Previous field treatment for AK within 2cm of the treatment area, within 3 months
- (non) melanoma skin cancer in treatment area
- Mucosal lesions
- Genetic skin cancer disorder
- Women who are pregnant or breastfeeding
- Women of childbearing potential, who are not willing to use effective contraceptive
measures
- Previous allergy or intolerance to either 5FU or calcipotriol
- Patients with known contra-indications for calcipotriol use: previous diagnosis of
hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction
- Concurrent use of oral capecitabine or any other topical or systemic chemopreventive
agent for any indication
- Concurrent use of other topical treatments registered as treatment for AK
- Limited understanding of the Dutch language and not being able to give informed
consent (incapacitated patients)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Catharina Hospital Eindhoven
Address:
City:
Eindhoven
Zip:
5623 EJ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Myrthe MG Moermans, MD
Phone:
0031433877295
Email:
myrthe.moermans@mumc.nl
Facility:
Name:
Zuyderland Medical Center
Address:
City:
Heerlen
Zip:
6419 HC
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Myrthe MG Moermans, MD
Phone:
0031433877295
Email:
myrthe.moermans@mumc.nl
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Myrthe MG Moermans, MD
Phone:
0031433877295
Email:
myrthe.moermans@mumc.nl
Facility:
Name:
VieCuri Medical Center
Address:
City:
Venlo
Zip:
5912 BL
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Myrthe MG Moermans, MD
Phone:
0031433877295
Email:
myrthe.moermans@mumc.nl
Start date:
September 4, 2024
Completion date:
March 2, 2029
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06499415
