Background: Despite widespread use of steroid-sparing agents, particularly cyclosporin, in the treatment of moderate to severe alopecia areata (AA), there are no prospective clinical trials investigating the efficacy of these agents.
Aims: To evaluate the efficacy of cyclosporin compared to placebo at 3 months in patients aged 18 to 65 years with moderate to severe AA.
Methods: A double-blind, randomised, placebo-controlled trial was conducted. Adults aged 18 to 65 years of age with moderate to severe AA were randomised in a 1:1 ratio to receive 3 months of cyclosporin (4mg/kg/day) or matching placebo. The study was powered to detect a 50% reduction in SALT score in 50% of participants. Blinded assessments were conducted monthly and included: physical examination, blood biochemistry, photography, quality of life measurements and efficacy evaluation using Severity of Alopecia Tool (SALT) score, eyelash and eyebrow assessment scales. A per protocol analysis was performed at 3 months of treatment.
Results: 32 participants (cyclosporin: 16; placebo: 16) were analysed. The baseline mean SALT score was 79.4%. The mean duration of current AA episode was 6.5 years. While the cyclosporin group had a greater mean reduction in SALT score (14.8% versus 2.3%; p=0.23) and greater proportion of participants achieving at least a 50% reduction of SALT score (31.3% versus 6.3%; p=0.07) compared to placebo at 3 months, this was not statistically significant.
Conclusion: Response approached but did not reach a statistically significant difference between cyclosporin and placebo. A larger sample size and longer treatment duration may detect lower response rates.