NCT01354717

Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo

Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Spear Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomized, placebo-controlled, three treatment parallel study in which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be counted at the baseline visit and at the visit four weeks following cessation of treatment.

Detailed description

actinic keratosis

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Brand Carac	treatment of actinic keratosis
DRUG	Generic 0.5% 5-fluorouracil cream	treatment of actinic keratosis
OTHER	Placebo cream	treatment of actinic keratosis

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-05-17
• Last updated: 2014-10-20