Inosiplex for Treatment of Alopecia Areata: a Randomized Placebo-controlled Study
Sofia Georgala, Alexander C. Katoulis, Angeliki Befon, Katerina Georgala and Panagiotis G. Stavropoulos
Treatment of alopecia areata remains unsatisfactory. We decided to test if systemic therapy with inosiplex (Isoprinosine®), an immunomodulator could influence the disease. Thirty-two subjects with recalcitrant alopecia areata, aged 16–48 years (mean 30.3±5.1 years), were randomized into two treatment groups of 16 subjects each. They were assigned to receive either oral inosiplex (group 1), or placebo (group 2) on a double-blind basis. Inosiplex dosage was 50 mg/kg/day in five divided doses for 12 weeks. Of the 15 evaluable patients in group 1, 5 (33.3%) had full remission, 8 (53.3%) responded partially and 2 (13.3%) did not respond. Of the 14 evaluable patients in the placebo group, none had full remission, 4 (28.5%) responded partially and 10 (71.4%) did not respond. The therapeutic difference between patients receiving active and placebo therapy was statistically significant (χ2=7.82, p<0.01). Compared with placebo, oral inosiplex showed considerable efficacy in alopecia areata with insignificant side-effects. Larger studies are required, however, before inosiplex may be recommended as an efficacious and safe alternative systemic form of therapy for recalcitrant alopecia areata.