Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499415
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis a Multicentre Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM
Brief 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 747 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None