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


METHODS
Randomised, double blind, placebo controlled studies.


METHODS
Private practices and university clinics in the United States.


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


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


METHODS



RESULTS
patient/wart response, times to complete response, recurrence rates.


RESULTS
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.


CONCLUSIONS
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.
Swinehart
J M
JM
Colorado Medical Research Center, Denver 80210, USA.
Skinner
R B
RB
McCarty
J M
JM
Miller
B H
BH
Tyring
S K
SK
Korey
A
A
Orenberg
E K
EK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003218:Condylomata Acuminata / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004338:Drug Combinations; D004837:Epinephrine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D005782:Gels; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D005782:Gels; D005472:Fluorouracil; D004837:Epinephrine