A Randomized Placebo-Controlled Single-Center Pilot Study of the Safety and Efficacy of Apremilast in Subjects with Moderate-to-Severe Alopecia Areata

In a pilot study from 2018, 30 patients with moderate-to-severe alopecia areata were randomized to receive either apremilast (20 patients) or a placebo (10 patients) over 24 weeks to test the drug's safety and efficacy. The primary goal was a 50% reduction in Severity of Alopecia Tool (SALT) score at 24 weeks. The results showed that apremilast was not significantly effective, with only 1 of 12 subjects in the apremilast group and 1 of 8 in the placebo group meeting the primary endpoint. The mean improvement in SALT score was not significantly different between the two groups. The study concluded that apremilast did not demonstrate efficacy in treating moderate-to-severe alopecia areata and suggested that the PDE4 pathway might not be significantly involved in the condition's pathogenesis. Adverse events were similar in both groups, with nausea being the most common in the apremilast group. The authors recommended larger studies to confirm these findings and suggested that PDE4 inhibition might still be beneficial for patients with milder forms of the condition.