Randomised double-blind trial of recombinant interferon-beta for condyloma acuminatum.
OBJECTIVE
To evaluate the safety and efficacy of two intralesional doses of recombinant human interferon-beta (r-hIFN-beta: Rebif, Ares Serono), given 3 times a week for 3 weeks, in the treatment of condyloma acuminatum.


METHODS
A randomised, double-blind, within-patient, placebo-controlled study.


METHODS
25 patients (24 males, 1 female) with a history of condyloma acuminatum. Twenty had failed previous treatment for condyloma acuminatum. In each patient, 3 distinct lesions were selected for treatment. Each selected lesion was randomly assigned to receive intralesionally one of the following: r-hIFN-beta 33,000 IU/day, r-hIFN-beta 1 x 10(6) IU/day, or matching placebo.


METHODS
Institut Alfred Fournier, Paris, France.


METHODS
Response was evaluated colposcopically at the end of treatment (day 22) and 5 weeks later (month 2). Complete response (CR) was defined as disappearance of the treated lesion. Partial response (PR) was defined as at least a 50% reduction in size, but not disappearance of the treated lesion.


RESULTS
The higher dose of 1 x 10(6) IU achieved significantly more complete and partial remissions than placebo, both by the end of treatment, and 5 weeks later.


CONCLUSIONS
r-hIFN-beta appears to be safe and effective when administered intralesionally to patients with condyloma acuminatum. Most of the treated patients had failed previous treatments and were therefore a resistant population.
Monsonego
J
J
Institut Alfred Fournier, Paris, France.
Cessot
G
G
Ince
S E
SE
Galazka
A R
AR
Abdul-Ahad
A K
AK
D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003218:Condylomata Acuminata / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
D000998:Antiviral Agents; D011994:Recombinant Proteins; D016899:Interferon-beta