Sofpironium may reduce disease severity in primary axillary hyperhidrosis: Study
Japan: Following 1-week treatment with 5% sofpironium bromide gel for patients with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 resulted in a clinically significant improvement, says a recent study in the Journal of Dermatology.
According to the study, after 1-week treatment with sofpironium, approximately 50% of the patients achieved an HDSS score of 1 or 2, which implies a clinically significant improvement for the patients.
5% sofpironium bromide (ECCLOCK) gel (hereinafter referred to as sofpironium) was approved in Japan in 2020 for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium showed the safety and efficacy of sofpironium; however, no study has investigated its early efficacy at <6 weeks after starting treatment.
To assess the earlier effectiveness of sofpironium, Tomoko Fujimoto, Ikebukuro Nishiguchi Fukurou Dermatology Clinic, Tokyo, Japan, and colleagues conducted a 2-week, single-center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis.
Patients aged ≥20 years and satisfying with an HDSS score of 3 or 4 at baseline were eligible for the study. A change in the proportion of patients with an HDSS score of 1, 2, 3, or 4 during the 2-week study period was the primary endpoint. There were more women than men (93.8% vs. 6.3%) in 80 patients included in the full analysis set (FAS), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years.
Salient findings of the study include:
- In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline.
- Mean HDSS scores (±SD) were significantly decreased from the baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7.
- The median period for sofpironium treatment to achieve an HDSS score of 1 or 2 for a continuous 2 days was 6 days.
- Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks.
To conclude, "a 2-week prospective observational study of sofpironium in Japanese patients with primary axillary hyperhidrosis indicates that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, about 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients."
Reference:
Fujimoto T, Okatsu H, Miyama H. Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis. J Dermatol. 2022 Apr 8. doi: 10.1111/1346-8138.16384. Epub ahead of print. PMID: 35394087.
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