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NCT03727074 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
A Phase 3 study, sponsored by Sol-Gel Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
NCT03727074: Completed Phase 3 study, sponsored by Sol-Gel Technologies.
NCT03727074 is a Phase 3 study that has completed, run by Sol-Gel Technologies. The registered enrollment target is 462 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03727074, a Phase 3 study, has completed, sponsored by Sol-Gel Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
Study Summary
To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.
Primary Outcome
Proportion of subjects, in the Per-Protocol (PP) population, with treatment success, defined as complete clearing (100% clearance of all AK lesions within the designated treatment area) at the End of Study visit
Interventions
- DRUG Vehicle
- DRUG 5-FU Cream
- DRUG Efudex®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2019-12-19 |
| Phase | Phase 3 |
What the finished NCT03727074 record still lists
NCT03727074 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.
NCT03727074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03727074 about?
NCT03727074 is a clinical study titled "Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream". To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.
What is the current status of trial NCT03727074?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2018-12-21. Estimated completion is 2019-12-19.
What interventions are being tested in trial NCT03727074?
The interventions under investigation include: Vehicle (DRUG), 5-FU Cream (DRUG), Efudex® (DRUG).
Who is sponsoring clinical trial NCT03727074?
This trial is sponsored by Sol-Gel Technologies, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03727074's enrollment target sits among peer trials
462 821st of 2000 higher than 1,179 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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