Recombinant interferon beta gel as an adjuvant in the treatment of recurrent genital warts: results of a placebo-controlled double-blind study in 120 patients.
BACKGROUND
Pilot studies of adjuvant therapy with topically applied interferons (IFN) have shown promising results in reducing the recurrence of condylomata acuminata (CA).


OBJECTIVE
The aim of this multicenter placebo-controlled, double-blind study was to confirm the efficacy and safety of topically applied IFN in a large sample of patients.


METHODS
After removal of CA by CO2 laser surgery, electrocautery or cryosurgery, 120 patients applied either recombinant IFN-beta (0.15 or 1.0 x 10(6) IU/g) or placebo gel to the affected areas 5 times daily for 4 weeks. The patients were followed for a total of 24 weeks or until recurrence of CA was observed, respectively.


RESULTS
In the 105 patients evaluated for efficacy after 24 weeks, recurrence rates were 75% (27/36 patients) in the placebo group, 62% (21/34) in the 1.0 x 10(6) IU/g group (n.s.) and 54% (19/35) in the 0.15 x 10(6) IU/g group (p = 0.034). Only few mild adverse events were noted, which were almost limited to the application site.


CONCLUSIONS
Topical application of gel containing 0.15 x 10(6) IU/g recombinant IFN-beta is safe and appears to reduce the recurrence of CA after surgical treatment.
Gross
G
G
Department of Dermatology, University of Hamburg, Germany.
Rogozinski
T
T
Schöfer
H
H
Jabłońska
S
S
Roussaki
A
A
Wöhr
C
C
Brzoska
J
J
D000279:Administration, Cutaneous; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003218:Condylomata Acuminata / Q000188:drug therapy* / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012871:Skin Diseases / Q000188:drug therapy* / Q000517:prevention & control; D016896:Treatment Outcome
D000998:Antiviral Agents; D011994:Recombinant Proteins; D016899:Interferon-beta