Botanical drug solution leads to sustained hair regrowth in paediatric alopecia

Coacillium, a solution containing plant extracts, led to sustained hair regrowth up to 24 weeks off-treatment and improved the quality-of-life of children and adolescents with alopecia areata (AA) in the phase 2/3 RAAINBOW trial.

A remaining unmet need in AA is an approved drug with a favourable benefit/risk profile for children and adolescents [1]. Recently, the randomised, double-blind, multicentre, phase 2/3 RAAINBOW trial (NCT03240627) assessed the efficacy and safety of the botanical drug solution coacillium (22.3%). RAAINBOW enrolled 62 participants aged 2–18 years with a Severity of Alopecia Tool (SALT) score of 25–50 (i.e. moderate AA) and 50–95 (i.e. severe AA). The SALT score is a weighted sum of the percentage of hair loss in the 4 quadrants of the scalp, ranging from 0 (i.e. no hair loss) to 100 (i.e. complete hair loss).

The solution met the primary endpoint with a mean change in SALT score of +22.9%, versus -8.0% in the placebo group (P<0.0001), and 26% even achieved at least a 40% relative reduction in SALT score [1]. Prof. Bianca Piraccini (University of Bologna, Italy) presented further results of the RAAINBOW study [2].

After coacillium discontinuation, SALT continued to improve from up to week 48, 24 weeks after the last application of the solution (see Figure). Of the participants treated with the botanical solution, 82% experienced hair growth after treatment discontinuation. Efficacy was positively correlated with improved quality-of-life, assessed in 2 different quality-of-life questionnaires.

Figure: Continued improvement in SALT scores after coacillium discontinuation [2]

FAS, full analysis set; SALT, Severity of Alopecia Tool.

At week 48, almost half (46.7%) of the participants in the intervention arm achieved SALT scores ≤20 (compared with 9.1% in the placebo group; P=0.0031), a third of participants even gained a SALT score ≤10 (compared with 0% in the placebo group; P=0.0065). The average relative SALT change for responders to coacillium treatment was 41%.

The solution was generally well tolerated. As Prof. Piraccini emphasised in her conclusion, coacillium is the first drug to show sustained remission off-treatment in alopecia areata. The solution is rapidly absorbed by the hair follicle and is easy to apply.

Relevant reading:

• Botanical drug solution improves hair regrowth in children and adolescents with AA  (EADV 2023)

1. 
   
   1. Blume-Peytavi U, et al. 1L, EADV Congress 2023, 11–14 October, Berlin, Germany.
   2. Piraccini BM. Efficacy and safety of coacillium in children and adolescents with moderate to severe alopecia areata: a randomised, double-blind, placebo-controlled, international, phase 2-3 trial. LB1, 2024 AAD Annual Meeting, 8­–12 March, San Diego, USA.

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Posted on 22 April 202417 May 2024