Cyclosporine for moderate-to-severe alopecia areata: A double-blind, randomized, placebo-controlled clinical trial of efficacy and safety.

Abstract

Despite widespread use of steroid-sparing agents, particularly cyclosporine, for treatment of alopecia areata (AA), there are no clinical trials investigating the efficacy of these agents. To evaluate the efficacy of cyclosporine compared with placebo at 3 months in patients aged 18 to 65 years with moderate-to-severe AA. A double-blind, randomized, placebo-controlled trial was conducted. Adults aged 18 to 65 years of age with moderate-to-severe AA were randomized in a 1:1 ratio to receive 3 months of cyclosporine (4 mg/kg/d) or matching placebo. Blinded assessments included physical examination, blood biochemistry, photography, quality of life measurements, and efficacy evaluation using Severity of Alopecia Tool score and eyelash and eyebrow assessment scales. The results obtained for 32 participants (16 who received cyclosporine and 16 who received placebo) were analyzed. Compared with the placebo group, the cyclosporine group had a greater proportion of participants achieving at least a 50% reduction in Severity of Alopecia Tool score (31.3% vs 6.3% [P = .07]) and greater proportion of participants achieving a 1-grade improvement in eyelash (18.8% vs 0% [P = .07]) and eyebrow (31.3% vs 0% [P = .02]) scale score. Small sample size and single-institution trial may limit interpretation and generalizability of these results. Response approached but did not reach a statistically significant difference between cyclosporine and placebo.