Effect of a 1-week treatment with 0.5% topical fluorouracil on occurrence of actinic keratosis after cryosurgery: a randomized, vehicle-controlled clinical trial.
BACKGROUND
No long-term randomized controlled clinical trial has compared the efficacy of cryosurgery alone vs cryosurgery following fluorouracil applications for the treatment of actinic keratosis.


OBJECTIVE
To determine the 6-month outcome of a 1-week course of 0.5% fluorouracil followed by cryosurgery.


METHODS
Prospective, multicenter, randomized, double-blind, vehicle-controlled clinical trial performed in community and academic outpatient clinics.


METHODS
A total of 144 patients with 5 or more visible or palpable actinic keratoses on the face.


METHODS
Topical 0.5% fluorouracil or vehicle once daily for 7 days. At the 4-week follow-up visit, residual lesions were treated with cryosurgery.


METHODS
Reduction in facial actinic keratoses from baseline to 4 weeks and 6 months.


RESULTS
At 4 weeks, mean actinic keratosis lesion count was reduced by 62.4% in the 0.5% fluorouracil group vs 28.8% in the vehicle group (P<.001), and complete clearance was achieved in 16.7% of patients in the 0.5% fluorouracil group vs 0% of those in the vehicle group (P<.001). At 6 months, mean lesion count was reduced by 67.0% in the 0.5% fluorouracil plus cryosurgery group vs 45.6% in the vehicle plus cryosurgery group (P =.01), and significantly more patients in the 0.5% fluorouracil plus cryosurgery group than in the vehicle plus cryosurgery group had complete clearance (30% vs 7.7%; P<.001).


CONCLUSIONS
A 1-week course of topical 0.5% fluorouracil before cryosurgery is significantly more effective in reducing patients' numbers of actinic keratosis lesions 6 months after treatment than cryosurgery alone. The high occurrence rate of actinic keratosis lesions at 6 months suggests a need for follow-up.
Jorizzo
Joseph
J
Department of Dermatology, Clinical Sciences Building 9th Floor, Wake Forest University School of Medicine, Winston-Salem, NC 27157-1071, USA.
Weiss
Jonathan
J
Furst
Katharine
K
VandePol
Christine
C
Levy
Sharon F
SF
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D003452:Cryosurgery; D004311:Double-Blind Method; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007642:Keratosis / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States
D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil