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A Phase 3 Clinical Study

James M. Swinehart, MD; Malcolm Sperling, MD; Stephen Phillips, MD; Stephen Kraus, MD; Stephen Gordon, MD; James M. McCarty, MD; Guy F. Webster, MD, PhD; Robert Skinner, MD; Andrew Korey, PhD; Elaine K. Orenberg, PhD

Arch Dermatol. 1997;133(1):67-73.

Abstract
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

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.

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