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NCT05699603 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Actinic Keratosis, sponsored by University of Arizona.
- Active
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 4
- Study locations
NCT05699603: Active Phase 2 study of Actinic Keratosis, sponsored by University of Arizona.
NCT05699603 is a Phase 2 study of Actinic Keratosis that is active but no longer recruiting, run by University of Arizona. The registered enrollment target is 56 participants, below the 185-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (70% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05699603, a Phase 2 study of Actinic Keratosis, is active but no longer recruiting, sponsored by University of Arizona.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Will be assessed at one day after completing one and two courses of calcipotriene plus 5-FU immunotherapy compared with before treatment. Paired t test will be performed to evaluate whether the changes from baseline are significantly different from 0.
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
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
What the registry record for NCT05699603 still lists
NCT05699603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 185-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (70% lower).
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.
NCT05699603 reports a single indexed study location in Arizona, Massachusetts, Missouri.
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.
What interventions are being tested in trial NCT05699603?
The interventions under investigation include: Biopsy (PROCEDURE), Fluorouracil (DRUG), Calcipotriene (DRUG).
Who is sponsoring clinical trial NCT05699603?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05699603's enrollment target sits among peer trials
56 11th of 16 higher than 6 of 16 other Actinic Keratosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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