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NCT04091022 · ClinicalTrials.gov registry record · Phase 2
Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT04091022: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT04091022 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04091022, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.
Primary Outcome
The purpose of the study is to determine whether participants randomized to a combination of two FDA approved topical medications topical diclofenac and topical DFMO have a significant change in incidence of (≥ 50% change, p ≤ 0.05) non-melanoma skin cancers (NMSC) than participants randomized to placebo as assessed by clinical and histopathological evaluation.
Interventions
- DRUG Solaraze and Vaniqa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2025-12-11 |
| Phase | Phase 2 |
What the finished NCT04091022 record still lists
NCT04091022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which Solaraze and Vaniqa is the first listed.
NCT04091022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04091022 about?
NCT04091022 is a clinical study titled "Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer". This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.
What is the current status of trial NCT04091022?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2021-01-18. Estimated completion is 2025-12-11.
What interventions are being tested in trial NCT04091022?
The interventions under investigation include: Solaraze and Vaniqa (DRUG).
Who is sponsoring clinical trial NCT04091022?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04091022's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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