Oral isotretinoin in the treatment of recalcitrant condylomata acuminata of the cervix: a randomised placebo controlled trial.

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.