The botanical drug solution coacillium® (22.25%) contains extracts of lemon, onion, cocoa, and guarana. The drug reduces pro-inflammatory adhesion molecules thus counteracting the immune privilege collapse typical for AA and has also an effect on the apoptotic pathway. This was the rationale for assessing the efficacy and safety of this solution in children and adolescents with moderate-to-severe AA1.
Prof. Ulrike Blume-Peytavi (Charité – Universitätsmedizin Berlin, Germany) presented the randomised, double-blind, multicentre, phase 2/3 trial RAAINBOW (NCT03240627) included AA patients aged 2–18 years with a Severity of Alopecia Tool (SALT) score of 25–50 (corresponding to moderate AA) and 50–95 (severe AA). They were randomly assigned to the botanical solution (22.5%) twice daily or placebo and treated for 24 weeks. This period was followed by a treatment-free period of 24 weeks to evaluate disease relapse after treatment discontinuation.
At 24 weeks, 62 participants with an average age of 11 years could be analysed (42 in the intervention arm and 20 in the placebo arm). Treatment with the botanical solution led to the primary endpoint of a mean change in SALT score of 22.9% in the coacillium® group versus -8.0% in the placebo group (P<0.0001). Moreover, 26.2% in the coacillium® group achieved a 40% relative reduction in SALT after 24 weeks of treatment compared with 5% in the placebo group. Efficacy was positively correlated with an improvement in quality of life.
Interestingly, SALT score of the botanical solution-treated participants continued to improve after treatment discontinuation, from 44 to 29. After discontinuation, 82% of participants treated with the botanical solution experienced hair growth after treatment discontinuation. At week 48, almost half of the participants (47%) in the intervention arm reached SALT scores ≤20 compared with 9.1% in the placebo group (P=0.0031).
The solution was well tolerated with only local transient, mild, or moderate side effects, except for 1 case of severe transient eczema that stopped after treatment discontinuation.