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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical 5FU-CAL, twice daily, during 4 or 6 consecutive days | Experimental | Treatment duration is based on treatment location |
|
| topical 5FU, twice daily, 7 days a week, during 4 weeks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5FU-Calcipotriol | Drug | topical 5FU-CAL, twice daily, during 4 or 6 consecutive days, depending on the treatment location |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success at 12 months post-treatment | Treatment success at 12 months post treatment, defined as ≥75% reduction in the number of AK lesions in the treatment area (partial clearance) | 12 months after finishing treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AK clearance rate | mean percentage change in AK lesions at 3 and 12 months post-treatment | 3 and 12 months after finishing treatment |
| Recurrence rate | New lesions and need for retreatment at 3 and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term risk for cSCC | The long-term probability of developing a cSCC | at least 3 years post-treatment |
Inclusion Criteria:
Adults above 18 years of age
Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more area(s):
Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2
AK Olsen grade I-III
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myrthe MG Moermans, MD | Contact | 0031433877295 | myrthe.moermans@mumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuyderland Medical Center | Recruiting | Heerlen | Limburg | 6419 HC | Netherlands |
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The investigator, who is also a physician and will evaluate treatment effect, is blinded to the allocated treatment
| 5-FU 50 MG/ML Topical Cream | Drug | topical 5FU, twice daily, 7 days a week, during 4 weeks |
|
| 3 and 12 months after finishing treatment |
| Adverse effects | Patients experiencing moderate to severe adverse effects | During treatment and 3 months post-treatment |
| Treatment compliance | Patients who are fully compliant to the prescribed treatment regimen (5FU-CAL or 5FU monotherapy) | During treatment |
| Patient satisfaction | Patients who express to be satisfied with their treatment | 3 and 12 months post-treatment |
| Quality of life before, during and after treatment | The mean score for quality of life on the Skindex-17 questionnaire. The Skindex-17 questionnaire has 17 items investigating the quality of life on different domains. The questions are answered on a five-point scale. A higher score represents a higher impact on QoL. | Baseline, 1 week after finishing treatment and 3 and 12 months post-treatment |
| Maastricht University Medical Center | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
|
| VieCuri Medical Center | Recruiting | Venlo | Limburg | 5912 BL | Netherlands |
|
| Catharina Hospital Eindhoven | Recruiting | Eindhoven | North Brabant | 5623 EJ | Netherlands |
|
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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