Botanical drug solution improves hair regrowth in children and adolescents with AA

A drug solution containing extracts of lemon, onion, cocoa, and guarana significantly improved hair regrowth in children and adolescents with moderate to severe alopecia areata (AA). Moreover, the botanical solution led to continuous hair regrowth even after treatment discontinuation.

“AA has started a new area of treatment with the JAK inhibitors. However, a remaining unmet need is a drug with a benefit/risk profile allowing early intervention, especially in the paediatric population,” said Prof. Ulrike Blume-Peytavi (Charité – Berlin University Medicine, Germany) [1]. Early intervention after the first manifestation in infancy might prevent further disease progression or chronicity.

AA is driven by the trafficking of cytotoxic lymphocytes to the peri-follicular and intra-follicular regions, mediated by adhesion molecules. 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 AA.

Prof. Blume-Peytavi presented the randomised, double-blind, multicentre, phase 2/3 trial RAAINBOW (NCT03240627), which 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.

The SALT score of the botanical solution-treated participants continued to improve after treatment discontinuation, from 44 to 29 (see Figure). 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).

Figure: After coacillium discontinuation at week 24, SALT score continues to improve from 44 to 29 [1]



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.

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   1. Blume-Peytavi U, et al. Efficacy and safety of coacillium in children and adolescents with moderate to severe alopecia areata: a randomized, double-blind, multicentre, phase 2-3 trial. D1T01.1L, EADV Congress 2023, 11–14 October, Berlin, Germany.

 

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Posted on 28 November, 202328 March, 2024