Coacillium solution sustains adolescent alopecia areata improvement post-treatment
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Key takeaways:
- After 24 weeks of no treatment, 47% of coacillium-treated patients had a SALT score of 20 or less vs. 9.1% of placebo-treated patients.
- No serious adverse events were reported.
Coacillium solution 22.25% improved moderate to severe alopecia in children and adolescents while retaining results post-treatment, according to a study presented at the European Academy of Dermatology and Venereology 2023 Congress.
Researchers presented the findings from RAAINBOW, an international, double-blind, placebo-controlled, multicenter, phase 2/3 trial evaluating the efficacy and safety of coacillium solution in adolescents with moderate to severe alopecia areata (AA).
“Coacillium is among the first drugs to show sustained remission off-treatment in an autoimmune and inflammatory disease, with no immune-altering side-effects,” Saad Harti, CEO of Legacy Healthcare and one of the study’s authors, told Healio.
Coacillium is a cutaneous, botanical solution composed of Allium cepa, Citrus limon, Theobroma cacao and Paullinia cupana that has shown to positively impact hair follicle cycling and endothelial cell activation, making it a potential treatment for AA.
The study included 62 children and adolescents (mean age, 11 years; 45% girls) aged 2 to 18 years with severe (60%) or moderate (40%) AA.
Each patient was randomly assigned to apply coacillium solution 22.25% (n = 42) or placebo (n = 20) twice daily for 24 weeks, which was followed by a treatment-free period of another 24 weeks to evaluate relapse rates. The primary endpoint was a change in Severity of Alopecia Tool (SALT) scores, with 100 being the worst and 0 being the best, from baseline to week 24.
Results showed that after 24 weeks, patients treated with coacillium saw a mean SALT score improvement of 22.87%, whereas placebo-treated patients regressed by 8%.
During the treatment-free period, coacillium-treated patients continued to improve with SALT scores decreasing from 43.6 to 29.
By week 48, 47% of coacillium-treated patients had reached a SALT score of 20 or less compared with only 9.1% of placebo-treated patients (P = .0031).
All adverse events were local, transient, mild or moderate apart from one severe transient eczema case. No serious adverse events were reported.
Although the FDA recently approved Litfulo (ritlecitinib, Pfizer) — a Janus kinase (JAK) inhibitor and the only FDA-approved treatment for adolescents with severe AA — this treatment is not indicated for moderate AA, which the researchers call the largest population, or children. Further, JAK inhibitors lead to disease relapse after discontinuation, according to the study abstract.
“No head-to-head trial allowing to compare coacillium directly with any oral JAK inhibitor approved for AA has been conducted,” Harti explains. “Based on the above, oral JAK inhibitors and coacillium might be more complementary than competing treatments, but data to support this assumption are needed.”