NCT02616601

Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Fluorouracil Cream, 0.5% and Carac® (Fluorouracil) Cream, 0.5% in Subjects With Actinic Keratoses

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.

Detailed description

This is a multicenter, double-blind, vehicle-controlled, parallel group comparison study of a generic fluorouracil cream, 0.5% and Carac (fluorouracil) Cream, 0.5% in participants with actinic keratoses on the full face or balding scalp.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Generic Fluorouracil Cream	Topical cream, generic formulation of the brand product.
DRUG	Carac® (Fluorouracil) Cream	Topical cream, brand product.
DRUG	Vehicle Cream	Topical cream, placebo. Has no active ingredient.

Timeline

• Start date: 2015-02-27
• Primary completion: 2015-09-17
• Completion: 2015-09-17
• First posted: 2015-11-30
• Last updated: 2019-07-17
• Results posted: 2019-07-17

Locations

17 sites across 1 country: United States