Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
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.