DEVELOPMENT OF INTRALESIONAL THERAPY WITH FLUOROURACIL ADRENALINE INJECTABLE GEL FOR MANAGEMENT OF CONDYLOMATA ACUMINATA - 2 PHASE-II CLINICAL-STUDIES/

Objectives: To evaluate a sustained release chemotherapy for treating condylomata acuminata with an injectable gel containing fluorouracil a nd adrenaline (5-FU/adrenaline gel). Study 1-To assess contributions o f 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 st udies. Setting: Private practices and university clinics in the United States. Patients: Men and women with new, recurrent, or refractory ex ternal condylomata acuminata. Intervention: Six injections over 8 week s; follow up visits at weeks 1, 4, 8, and 12. Main outcome measures: E fficacy: 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 gr oup, followed by the 5-FU/adrenaline solution group, then the 5-FU gel group. 5-FU, adrenaline, and the collagen gel vehicle (in the presenc e of 5-FU) significantly affected CR and strongly influenced time to C R. The effects of 5-FU and adrenaline were statistically significant. Cutaneous reactions were mild to moderate. Study 2: 187 evaluable pati ents. Patients treated with 5-FU/adrenaline gel had a significantly hi gher CR rate and lower cumulative 90 day recurrence rate than those tr eated 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 variou s combinations of components, this formulation provided the greatest t herapeutic advantage.