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NCT05699603
Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients
Phase 2 trial testing Biopsy in Actinic Keratosis in 56 participants. Participants enrolled and being followed up; not accepting new ones.
1 February 2027
Quick facts
| Lead sponsor | University of Arizona |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 56 |
| Start date | 2 July 2024 |
| Primary completion | 1 February 2027 |
| Estimated completion | 1 February 2029 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Biopsy — full drug profile →
- Calcipotriene (CALCIPOTRIENE) — full drug profile →
- Fluorouracil — full drug profile →
Conditions studied
- Actinic Keratosis — all drugs for Actinic Keratosis →
Sponsor
University of Arizona
Who can join
18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients. Solid organ transplant recipients are at high risk of developing skin cancer. Actinic keratosis (AK), is a premalignant skin lesion that can progress to squamous cell skin cancer. In this study, solid organ transplant recipients with multiple AKs are treated with topical calcipotriene and 5-FU to evaluate how effective this therapy is against AKs and if this could lower their risk of skin cancer. Topical calcipotriene is a form of vitamin D and is used to treat psoriasis. Prior research reported immunomodulatory effects in the skin induced by topical calcipotriene. Topical 5- fluorouracil is a chemotherapy agent and is one of the therapy options for multiple AKs in specific clinical scenarios. Prior research indicates that topical calcipotriene used together with topical 5-FU was more effective in treating multiple AKs than 5-FU alone in individuals with healthy immune system. This study is investigating now if similar beneficial effects can be seen in immunosuppressed individuals who are solid organ transplant recipients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Repurposing Drugs for Cancer Prevention: Targeting Mechanisms Common to Chronic Diseases.
Choradia N, Szabo E. · · 2024 · cited 1× · PMID 39312454 · DOI 10.1097/ppo.0000000000000746 -
Cancer Prevention Clinical Trials: Advances and Challenges.
Francis ER, Syed FZ, Rajan A, Szabo E. · · 2026 · PMID 41681861 · DOI 10.3390/cancers18030390
Verify or expand the search:
- PubMed search for NCT05699603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Actinic Keratosis
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05699603 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arizona
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05699603.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing