Intralesional fluorouracil/epinephrine injectable gel for treatment of condylomata acuminata. A phase 3 clinical study
J. M. Swinehart, M. Sperling, S. Phillips, S. Kraus, S. Gordon, J. M. McCarty, G. F. Webster, R. Skinner, A. Korey and E. K. Orenberg
Colorado Medical Research Center, Denver, USA.
BACKGROUND AND DESIGN: 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. CONCLUSION:
The fluorouracil/epinephrine injectable gel is a safe and effective
treatment for condylomata acuminata.
