NCT03727074

Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream, With Efudex® (5-FU) Cream, and Both Active Treatments to a Vehicle Control, in the Treatment of Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Sol-Gel Technologies, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To compare the safety and efficacy profiles of 5-FU Cream with 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.

Conditions

• Actinic Keratosis (AK)

Interventions

Type	Name	Description
DRUG	5-FU Cream	topical cream twice a day
DRUG	Efudex®	topical cream twice a day
DRUG	Vehicle	topical cream twice a day

Timeline

• Start date: 2018-12-21
• Primary completion: 2019-12-19
• Completion: 2019-12-19
• First posted: 2018-11-01
• Last updated: 2020-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study