Topical plant-based drug induces durable hair growth in children with moderate to severe AA

Twice-daily application of the botanical coacillium 22.25% cutaneous solution leads to significant hair growth in children and adolescents with moderate-to-severe alopecia areata (AA), with the improvement in hair loss sustained through months after treatment discontinuation, according to data from the phase II/III RAAINBOW trial.

Coacillium proved superior to placebo in terms of the primary endpoint of change in mean Severity of Alopecia Tool (SALT) score after 24 weeks of treatment. Mean SALT score decreased by 22.87 percent with coacillium (from 56 at baseline to 44 at week 24) and by 8.00 percent with placebo (from 62 at baseline to 61 at week 24; p<0.0001). This corresponded to a treatment effect of 30.87 percent. [EADV 2023, abstract 6533]

A total of 26.2 percent of children on coacillium achieved a 40-percent relative reduction in SALT score compared with only 5.0 percent of those on placebo (p=0.0484), reported lead study author Prof Ulrike Blume-Peytavi of Charité-Universitaetsmedizin Berlin in Berlin, Germany.

More importantly, the beneficial effect of coacillium was durable, Blume-Peytavi added.

After treatment discontinuation, mean SALT score in the coacillium arm further decreased from 44 at week 24 to 29 at week 48. Around 82 percent of patients experienced hair growth off-treatment. On the other hand, mean salt score in the placebo arm decreased only slightly from 61 at week 24 to 56 at week 48, with off-treatment hair growth occurring in 37 percent of patients.

At week 48, 46.7 percent and 30.0 percent of patients who completed treatment with coacillium achieved a SALT score of ≤20 and ≤10, respectively, as opposed to only 9.1 percent and 0.0 percent of those who completed treatment with placebo (p=0.0453 and p=0.0031, respectively).

Blume-Peytavi pointed out that the treatment benefit was associated with improved quality-of-life endpoints. In the coacillium arm, the Children's Dermatology Life Quality Index (CDLQI) score dropped and the EuroQol-visual analogue scale (EQ-VAS) scores rose as the mean SALT scores decreased. These improvements in quality of life were seen throughout the treatment and off-treatment periods.

In terms of safety, coacillium was well tolerated. Adverse events (AEs) in the coacillium arm were local, transient, and mild or moderate, with the exception of a single case of severe transient eczema. There were no reports of serious AEs.

Paradigm-shifting treatment

Coacillium is a botanical drug composed of Allium cepa, Citrus limon, Theobroma cacao, and Paullinia cupana. These four plant extracts have the “Generally Regarded As Safe” classification. These multiple components have been shown to act positively on both hair follicle cycling and endothelial cell activation, which are dysregulated in AA, according to Blume-Peytavi.

“To our knowledge, coacillium is among the first drugs to show sustained remission off-treatment in an autoimmune-mediated disease, without immune-altering side-effects,” she said.

Blume-Peytavi believes that the durable benefit of the botanical drug is transformational, given the lack of treatment option for moderate AA. Recently approved Janus kinase (JAK) inhibitors for AA, while representing a major advance in treatment, are only approved for severe AA in adults and adolescents only, leaving the children and patients with moderate AA unserved.

It is important that intervention is given after first manifestation in infancy, as this may possibly prevent disease progression or chronicity, she stressed. Aso, discontinuation of JAK inhibitor treatment leads to disease relapse.

Based on the findings from the RAAINBOW trial, coacillium may herald a potential paradigm shift in the treatment of children and adolescents with moderate-to-severe AA, with the botanical drug being a suitable treatment option for this population, according to Blume-Peytavi.

RAAINBOW included 62 children and adolescents (average age 11 years, 45 percent girls, mean time since AA onset 3 years), of whom 42 and 20 received coacillium and placebo, respectively. AA was severe in 60 percent of patients and moderate in the remaining 40 percent. Fifty-two percent of patients had their first episode of AA, whereas 48 percent had their second flare or more.