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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 is a Phase 3 study that has completed, run by Sol-Gel Technologies. The registered enrollment target is 462 participants.

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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.

Interventions

  • DRUG Vehicle
  • DRUG 5-FU Cream
  • DRUG Efudex®

Trial Details

FieldValue
Enrollment Target 462 participants
Start Date 2018-12-21
Est. Completion 2019-12-19
Phase Phase 3

Sponsor

Sol-Gel Technologies

15 total trials

What the Registry Record Tells You About NCT03727074

The ClinicalTrials.gov registry entry for NCT03727074 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sol-Gel Technologies, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.

NCT03727074 reports 0 study locations.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.