AICHI Study Reveals High Prevalence of Pediatric Axillary Hyperhidrosis in Japan and Promising Results with Sofpironium Bromide Gel

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Primary axillary hyperhidrosis affects a significant portion of the population, with prevalence studies largely focusing on adults until recently. In an effort to fill this gap, the AICHI study conducted aimed to investigate the epidemiology of primary axillary hyperhidrosis in Japanese children.

The study, presented in a poster at the 2024 Society for Pediatric Dermatology Annual Meeting in Toronto, ON, reported that sofpironium bromide gel was effective, safe, and satisfactory in young Japanese children with primary axillary hyperhidrosis.¹

Background and Methods

The study encompassed 3,983 children aged 6 to 14 years who visited dermatology clinics across Japan. Through a questionnaire-based survey, the researchers identified that 2.5% of these children exhibited severe primary axillary hyperhidrosis, characterized by a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4.

Using this data, the prevalence of primary axillary hyperhidrosis among children was calculated at 5.4%, aligning closely with previously reported figures for adults.

Among the 39 children with severe primary axillary hyperhidrosis who opted for treatment, sofpironium bromide gel was administered. Sofpironium bromide gel, approved in Japan in 2020 as the world's first drug specifically for primary axillary hyperhidrosis, had primarily been studied in adult populations during its clinical trials.²

Findings

Following 4 weeks of sofpironium bromide treatment treatment, researchers observed significant improvements across key measures including HDSS scores, Dermatology Life Quality Index, and sweating visual analog scale scores. Furthermore, no new adverse drug reactions necessitating special attention were reported among the pediatric cohort.

Conclusions

The AICHI study's findings underscore the comparable prevalence of primary axillary hyperhidrosis between children and adults in Japan, supporting the notion that this condition manifests similarly across age groups, according to poster authors Oshima et al.

Moreover, the study validates sofpironium bromide gel as an effective and well-tolerated treatment option for pediatric patients with severe axillary hyperhidrosis.

The US Food and Drug Administration recently approved Botanix Pharmaceutical's Sofdra, a 12.45% sofpironium topical gel, for adults and children aged 9 and older with primary axillary hyperhidrosis, marking it as the first and only approved chemical entity for this condition. Approval was based on positive phase 3 trial results showing significant symptom improvement in approximately 85% of over 700 patients, with no serious treatment-related adverse events reported.³

Sofdra, intended for once-daily use with an applicator to avoid hand contact, is marketed in Japan as Ecclock.

References

1. Oshima Y, Okatsu H, Watanabe D. Epidemiological study of primary axillary hyperhidrosis in children and the efficacy of sofpironium bromide gel (AICHI study) - A multicenter, prospective, observational study. Poster presented at the 2024 Society for Pediatric Dermatology Annual Meeting, July 11-14; Toronto, ON.
2. Paik J. Sofpironium bromide: First approval. Drugs. 2020;80(18):1981-1986. doi:10.1007/s40265-020-01438-1
3. FDA approval of Sofdra - the first new drug for primary axillary hyperhidrosis. News release. Botanix Pharmaceuticals. June 20, 2024. Accessed July 13, 2024. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299