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. DESIGN: A randomised, double-blind, within-patient, placebo-controlled study. SUBJECTS: 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. SETTING: Institut Alfred Fournier, Paris, France. OUTCOME MEASURES: 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.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of two intralesional doses of recombinant humaninterferon-beta (r-hIFN-beta: Rebif, Ares Serono), given 3 times a week for 3 weeks, in the treatment of condyloma acuminatum. DESIGN: A randomised, double-blind, within-patient, placebo-controlled study. SUBJECTS: 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. SETTING: Institut Alfred Fournier, Paris, France. OUTCOME MEASURES: 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.
Authors: A E Friedman-Kien; L J Eron; M Conant; W Growdon; H Badiak; P W Bradstreet; D Fedorczyk; J R Trout; T F Plasse Journal: JAMA Date: 1988 Jan 22-29 Impact factor: 56.272
Authors: L J Eron; F Judson; S Tucker; S Prawer; J Mills; K Murphy; M Hickey; M Rogers; S Flannigan; N Hien Journal: N Engl J Med Date: 1986-10-23 Impact factor: 91.245
Authors: R C Reichman; D Oakes; W Bonnez; C Greisberger; S Tyring; L Miller; R Whitley; H Carveth; M Weidner; G Krueger Journal: Ann Intern Med Date: 1988-05 Impact factor: 25.391
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Authors: Antoine Bertolotti; Brigitte Milpied; Sébastien Fouéré; Nicolas Dupin; André Cabié; Christian Derancourt Journal: Dermatol Ther (Heidelb) Date: 2019-10-13