Development of intralesional therapy with fluorouracil/adrenaline injectable gel for management of condylomata acuminata: two phase II clinical studies.

Abstract

Objectives: To evaluate a sustained release chemotherapy for treating condylomata acuminata with an injectable gel containing fluorouracil and adrenaline (5-FU/adrenaline gel). Study 1-- To assess contributions of the components of 5-FU/adrenaline gel to efficacy. Study 2--To assess therapeutic contribution of adrenaline and safety and efficacy of the formulations.

Design: Randomised, double blind, placebo controlled studies.

Setting: Private practices and university clinics in the United States.

Patients: Men and women with new, recurrent, or refractory external condylomata acuminata.

Intervention: Six injections over 8 weeks; follow up visits at weeks 1, 4, 8, and 12.

Main outcome measures:

Efficacy: patient/wart response, times to complete response, recurrence rates.

Safety: injection reactions, tissue conditions, other adverse events, laboratory studies.

Results: Study 1: 132 evaluable patients. Complete response (CR) rate was highest for the 5-FU/adrenaline gel group, followed by the 5-FU/adrenaline solution group, then the 5-FU gel group. 5-FU, adrenaline, and the collagen gel vehicle (in the presence of 5-FU) significantly affected CR and strongly influenced time to CR. The effects of 5-FU and adrenaline were statistically significant. Cutaneous reactions were mild to moderate. Study 2: 187 evaluable patients. Patients treated with 5-FU/adrenaline gel had a significantly higher CR rate and lower cumulative 90 day recurrence rate than those treated with 5-FU gel without adrenaline. Treatments were generally well tolerated, with only three treatment related, serious adverse events.

Conclusion: 5-FU/adrenaline gel is safe and efficacious for treatment of condylomata acuminata, and when compared with individual or various combinations of components, this formulation provided the greatest therapeutic advantage.