Randomized trial evaluating a new 0.5% fluorouracil formulation demonstrates efficacy after 1-, 2-, or 4-week treatment in patients with actinic keratosis.
The efficacy and safety of a new 0.5% fluorouracil topical cream were compared with vehicle control for the treatment of actinic keratosis (AK). Active treatment applied once daily for 1, 2, or 4 weeks was more effective than vehicle control in achieving reduction from baseline in lesion counts and lesion clearance. Active treatment also resulted in significantly better global assessments of overall improvement. Treatment was effective regardless of the number of baseline lesions. Although longer treatment duration correlated with greater efficacy, treatment for 1, 2, or 4 weeks was effective. This new microsphere-based fluorouracil formulation was generally well tolerated; adverse events were primarily limited to facial irritation that resolved quickly after treatment. This new treatment provides a safe alternative to the topical fluorouracil formulations currently available for the 1-, 2-, or 4-week treatment of AK.
Jorizzo
Joseph
J
Wake Forest University School of Medicine, Department of Dermatology, Clinical Sciences Building, Medical Center Blvd, Winston-Salem, NC 27157-1071, USA. jjorizzo@wfubmc. edu
Stewart
Daniel
D
Bucko
Alicia
A
Davis
Steven A
SA
Espy
Paul
P
Hino
Peter
P
Rodriguez
David
D
Savin
Ronald
R
Stough
Dow
D
Furst
Katharine
K
Connolly
Margaret
M
Levy
Sharon
S
D000287:Administration, Topical; D000328:Adult; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007642:Keratosis / Q000188:drug therapy*; D016018:Least-Squares Analysis; D008297:Male; D008863:Microspheres; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil