Ruxolitinib Cream for the Treatment of Patients With Alopecia Areata: A 2-Part, Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study

Abstract Background There are currently no universally effective or FDA-approved treatments for alopecia areata (AA). Oral ruxolitinib has shown efficacy in extensive AA. Ruxolitinib cream would potentially avoid systemic side effects. Objective To assess the efficacy and safety of 1.5% ruxolitinib cream in patients with AA who had ≥25% hair loss by Severity of Alopecia Tool (SALT) score. Methods This was a 2-part study. Part A was an open-label, 24-week study of 1.5% ruxolitinib cream in patients with 25%−99% hair loss followed by a 24-week extension period. Part B was a double-blind, vehicle-controlled, 24-week study of 1.5% ruxolitinib cream in patients with 25%−100% hair loss, followed by a crossover to ruxolitinib cream in the vehicle group for 24 weeks, and additional treatment time for the ruxolitinib cream group. Results Although Part A results suggested potential efficacy of 1.5% ruxolitinib cream, there was no significant difference in hair regrowth by SALT50 scores between patients on 1.5% ruxolitinib cream and vehicle in Part B. There were no significant safety issues with 1.5% ruxolitinib cream. Limitations Single strength of ruxolitinib cream Conclusions 1.5% ruxolitinib cream did not demonstrate a significant effect in patients with AA.