Spots Global Cancer Trial Database for Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo

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Trial Identification

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

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

Study ID: NCT01354717

Conditions

Actinic Keratoses

Interventions

Brand Carac

Generic 0.5% 5-fluorouracil cream

Placebo cream

Study Description

Brief 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