Intralesional fluorouracil/epinephrine injectable gel for treatment of condylomata acuminata. A phase 3 clinical study.
METHODS
A new intralesional sustained-release chemotherapy is under development as a treatment for condylomata acuminata; it is administered as an injectable gel that consists of fluorouracil and epinephrine with a purified bovine collagen as the gellant (fluorouracil/epinephrine gel). In this randomized, double-blind study, we evaluated the safety and efficacy of this intralesional treatment in 401 patients, using 2 active drug formulations (fluorouracil/epinephrine gel and fluorouracil gel alone) and a placebo. Each lesion was injected once a week for up to 6 weeks, and patients were followed up for 3 months.


RESULTS
A total of 359 patients with 1926 condylomata underwent evaluation. For all lesions treated with fluorouracil/epinephrine gel, the complete response (CR) rate was 77%. For all patients treated with fluorouracil/epinephrine gel, the CR rate was 61%. The fluorouracil/epinephrine gel was significantly more effective (P < .002) in treating condylomata than the fluorouracil gel without epinephrine (CR rate, 43%); both were superior to placebo (CR rate, 5%). At 3 months after completion of treatment, recurrence rates in patients with CRs were as follows: fluorouracil/epinephrine gel group, 50%; fluorouracil gel group, 58%. No clinically significant drug-related systemic reactions occurred. Finally, the type and severity of local tissue reactions of patients with a positive pretreatment collagen skin test result (6/401 [1.5%]) were similar to those of patients with a negative collagen skin test result.


CONCLUSIONS
The fluorouracil/epinephrine injectable gel is a safe and effective treatment for condylomata acuminata.
Swinehart
J M
JM
Colorado Medical Research Center, Denver, USA.
Sperling
M
M
Phillips
S
S
Kraus
S
S
Gordon
S
S
McCarty
J M
JM
Webster
G F
GF
Skinner
R
R
Korey
A
A
Orenberg
E K
EK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D003218:Condylomata Acuminata / Q000188:drug therapy*; D004311:Double-Blind Method; D004837:Epinephrine / Q000008:administration & dosage*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005782:Gels; D005831:Genital Diseases, Female / Q000188:drug therapy*; D005832:Genital Diseases, Male / Q000188:drug therapy*; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D012008:Recurrence
D000964:Antimetabolites, Antineoplastic; D005782:Gels; D005472:Fluorouracil; D004837:Epinephrine