Randomized, Vehicle-controlled Trials of Topical 5-fluorouracil Therapy for Actinic Keratosis Treatment

An Overview

Maral Rahvar; Sonia A Lamel; Howard I Maibach


Immunotherapy. 2012;4(9):939-945. 

In This Article


A database search of PubMed and Embase was performed from 1965 to April 2012 using the terms 'actinic keratoses', 'solar keratoses', 'topical 5-fluorouracil', 'topical 5-FU', 'double-blind', 'controlled trial', 'vehicle controlled trial' and 'precancerous skin lesions'. The medication names of the current FDA-approved topical agents for the treatment of AK including Carac® (Sanofi-Aventis, NJ, USA), Efudex® (Valeant, CA, USA) and Fluoroplex® (Allergan, CA, USA) were also incorporated.

Two reviewers screened the abstracts and articles obtained via database searching. Only randomized, double-blind, vehicle-controlled clinical trials written in English evaluating the efficacy of topical 5-FU in treatment of AK were included. Trials were excluded if they were open labeled, allowed the application of additional treatments other than topical corticosteroids, were comparator trials or had no vehicle control.

Data on participant characteristics including age, sex, race and skin type were abstracted. Additionally, information regarding inclusion criteria, exclusion criteria, lesion counts, randomization numbers, outcomes measures and adverse events were captured. We recorded medication concentration, dosage, administration schedule and length of therapy.