S Georgala1, A C Katoulis, C Georgala, E Bozi, A Mortakis. 1. National and Kapodistrian University of Athens, Department of Dermatology and Venereology, "A Sygros" Hospital, Athens, Greece. eykat@panafonet.gr
Abstract
BACKGROUND: Conventional therapies for human papillomavirus (HPV) infection are often associated with unsatisfactory response rates and high recurrence rates. The use of a systemic agent may more effectively control the virus. OBJECTIVES: To investigate the efficacy and safety of low dose oral isotretinoin in recalcitrant condylomata acuminata (RCA) of the cervix. METHODS: Double blind placebo controlled clinical trial. 60 women, aged 21-43 years, with RCA of the cervix, refractory to at least one conventional therapy, were randomly assigned to receive either isotretinoin, 0.5 mg/kg daily for 12 weeks (group 1), or placebo (group 2). RESULTS: Of the 28 evaluable group 1 patients, nine (32.1%) responded to the treatment completely, 11 (39.2%) responded partially, and eight (28.5%) did not respond. Of the 25 group 2 patients, no one responded to the treatment completely, two (8%) responded partially, and 23 (92%) did not respond. The therapeutic difference between patients receiving active and placebo therapy was statistically significant (chi(2) = 19.35, p<0.001). Only one (11.1%) of the complete responders experienced recurrence during the 12 month follow up. Side effects were generally mild and resolved upon completion of therapy. CONCLUSIONS: Compared to placebo, low dose oral isotretinoin showed considerable efficacy with insignificant and reversible side effects and a low recurrence rate. Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for RCA of the cervix.
RCT Entities:
BACKGROUND: Conventional therapies for human papillomavirus (HPV) infection are often associated with unsatisfactory response rates and high recurrence rates. The use of a systemic agent may more effectively control the virus. OBJECTIVES: To investigate the efficacy and safety of low dose oral isotretinoin in recalcitrant condylomata acuminata (RCA) of the cervix. METHODS: Double blind placebo controlled clinical trial. 60 women, aged 21-43 years, with RCA of the cervix, refractory to at least one conventional therapy, were randomly assigned to receive either isotretinoin, 0.5 mg/kg daily for 12 weeks (group 1), or placebo (group 2). RESULTS: Of the 28 evaluable group 1 patients, nine (32.1%) responded to the treatment completely, 11 (39.2%) responded partially, and eight (28.5%) did not respond. Of the 25 group 2 patients, no one responded to the treatment completely, two (8%) responded partially, and 23 (92%) did not respond. The therapeutic difference between patients receiving active and placebo therapy was statistically significant (chi(2) = 19.35, p<0.001). Only one (11.1%) of the complete responders experienced recurrence during the 12 month follow up. Side effects were generally mild and resolved upon completion of therapy. CONCLUSIONS: Compared to placebo, low dose oral isotretinoin showed considerable efficacy with insignificant and reversible side effects and a low recurrence rate. Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for RCA of the cervix.