A new topical botanical drug may help treat moderate-to-severe alopecia areata (AA) in kids and adults, according to Phase 2/3 results published in the British Journal of Dermatology.
Legacy Healthcare’s Cinainu is a topical botanical drug with anti-inflammatory, anti-apoptotic, and antioxidant properties.
The international, double-blind, placebo-controlled, phase 2/3 RAAINBOW trial enrolled 107 pediatric AA patients randomized (2:1) to Cinainu or placebo for 24 weeks, followed by a 24-week treatment-free follow-up period. The prespecified primary analysis included 62 patients with confirmed moderate-to-severe AA at baseline. The primary endpoint was the relative change in the Severity of Alopecia Tool (SALT) score from baseline to Week 24, where SALT measures the percentage of hair loss.
Cinainu showed significant benefits compared to placebo in the relative change in SALT score from baseline to Week 24, and benefits were sustained during the follow-up period. At Week 48, 47.6% of patients in the Cinainu group achieved a SALT score ≤20, and 35.7% reached a SALT score ≤10. Cinainu also led to significant quality of life improvements at Week 24. There were no serious adverse events reported in the Cinainu group, and treatment was well-tolerated, with a lower incidence of adverse events compared to the placebo group, the study showed.
