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ACTIVE NOT RECRUITING Phase 2

Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients

NCT05699603 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • PROCEDURE Biopsy
  • DRUG Fluorouracil
  • DRUG Calcipotriene

Study Locations (4)

Arizona

  • University of Arizona Cancer Center - Prevention Research Clinic — Tucson

Massachusetts

  • Massachusetts General Hospital Cancer Center — Boston

Missouri

  • Washington University School of Medicine — St Louis

Oregon

  • Oregon Health and Science University — Portland

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2024-07-02
Est. Completion 2029-02-01
Phase Phase 2

Sponsor

University of Arizona

379 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05699603

The ClinicalTrials.gov registry entry for NCT05699603 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 379 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 3 interventions — of which Biopsy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05699603 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, Massachusetts, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05699603 about?

NCT05699603 is a clinical study titled "Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients". 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 progr...

What is the current status of trial NCT05699603?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2024-07-02. Estimated completion is 2029-02-01.

What conditions does trial NCT05699603 study?

This clinical trial studies the following conditions: Actinic Keratosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05699603?

The interventions under investigation include: Biopsy (PROCEDURE), Fluorouracil (DRUG), Calcipotriene (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05699603?

This trial is sponsored by University of Arizona, which has 379 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05699603 being conducted?

This trial has 4 study locations across Arizona, Massachusetts, Missouri, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial