Clinical trial · Observational
5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses
NCT07794059CI-TRIAL-00124644not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
Combination field therapy with 5-fluorouracil and calcipotriene (5FU/C) has become standard of care among dermatologists for the field treatment of diffuse actinic keratoses (AKs). Data suggest that the addition of calcipotriene elicits a sustained T cell memory allowing for both short and long-term AK clearance. Our objective is to evaluate the efficacy, as well as, document the timing, severity and duration of local cutaneous reactions to topical treatment with 5FU/C for the treatment of AKs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination field therapy with 5-fluorouracil and calcipotriene (5FU/C) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the clinical efficacy of 5FU/C to treat Actinic Keratoses
- timeFrame
- 9 Weeks
- description
- Our primary endpoint is the percent change from baseline in total AKs at week 9. Secondary endpoints include complete (100%) and partial (75%) clearance of AKs at week 9. These endpoints mirror prior pivotal trials of 5FU/C and will directly evaluate whether immunosuppression reduces clinical efficacy of 5FU/C to treat AKs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals 18 years old or older are included * Presence of 4 to 15 clinically visible and discrete actinic keratoses in a 100-cm2 contiguous area on the face, non-hair bearing scalp, or the upper extremities (including the hand). * Solid organ transplantation (kidney, lung, heart, liver, and/or pancreas) on immunosuppressive medications for at least one year prior to the start of the study Exclusion Criteria: * Active skin cancer * Recent use of field cancerization within the preceding 12 months in the field of treatment * Use of nicotinamide or vitamin A derivatives (which are systemic agents intended for NMSC prevention). * Any records flagged "break the glass" or "research opt out." * Allergy or hypersensitivity to 5-Fluorouracil or Calcipotriene or inactive components of compounded product * Pregnant and breastfeeding patients * Allergy to peanut as some formulation of 5FU may contain peanut oil. * Allergy or hypersensitivity to Trolamine-NF, PenDerm Cream Base, and Propylene Glycol
References
Publications (0)
Data not yet available
No reference posted for this study.