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.
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.
The fluorouracil/epinephrine injectable gel is a safe and effective treatment for condylomata acuminata.Arch Dermatol. 1997;133:67-73
Swinehart JM, Sperling M, Phillips S, Kraus S, Gordon S, McCarty JM, Webster GF, Skinner R, Korey A, Orenberg EK. Intralesional Fluorouracil/Epinephrine Injectable Gel for Treatment of Condylomata AcuminataA Phase 3 Clinical Study. Arch Dermatol. 1997;133(1):67-73. doi:10.1001/archderm.1997.03890370073011