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January 1997

Intralesional Fluorouracil/Epinephrine Injectable Gel for Treatment of Condylomata Acuminata: A Phase 3 Clinical Study

Author Affiliations

From the Colorado Medical Research Center, Denver (Dr Swinehart); Future Healthcare Research Center, Altamonte Springs, Fla (Dr Phillips); Georgia Clinical Research Center Inc (Dr Kraus) and Crucible Group Inc (Dr Gordon), Atlanta, Ga; the Department of Dermatology, Thomas Jefferson University Medical College, Philadelphia, Pa (Dr Webster); the Department of Dermatology, University of Tennessee, Memphis (Dr Skinner); and Matrix Pharmaceutical Inc, Fremont, Calif (Drs Korey and Orenberg). Dr Sperling is in private practice in Fountain Valley, Calif, and Dr McCarty is in private practice in Fresno, Calif.

Arch Dermatol. 1997;133(1):67-73. doi:10.1001/archderm.1997.03890370073011

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 drugrelated 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.Arch Dermatol. 1997;133:67-73