Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

Abstract

In 2020, 5% sofpironium bromide (ECCLOCK^® ) gel (hereinafter referred to as sofpironium) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium demonstrated the efficacy and safety of sofpironium; however, no study has assessed its early efficacy at <6 weeks after starting treatment. Therefore, to assess the earlier effectiveness of sofpironium, we conducted a 2-week, single-center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis. Patients aged ≥20 years and satisfying with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline were eligible for the study. The primary endpoint for the effectiveness was change in the proportion of patients with a HDSS score of 1, 2, 3, or 4 during the 2-week study period. In 80 patients included in the full analysis set (FAS), there were more women than men (93.8% vs. 6.3%), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years. 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 (p < 0.05). Mean HDSS scores (±SD) were significantly decreased from baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7 (p < 0.001). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2 days was 6 days (95% confidence interval, 4-8). Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks. These results suggest that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.

Keywords: 2-week study; Hyperhidrosis Disease Severity Scale score; early effectiveness; primary axillary hyperhidrosis; sofpironium bromide gel.

FIGURE 1

Change in proportion of patients with a HDSS score of 1, 2, 3, or 4 (FAS). The number of patients evaluated was 80 included in the FAS from day 0 to day 14. *p < 0.05, **p < 0.001 (comparison of proportion of patients with a HDSS score of 1 or 2 using a one‐sample proportion test, vs. day 0). The asterisks indicate that the proportion is significantly higher than the hypothesized value (p = 0.282). Abbreviations: FAS, full analysis set; HDSS, Hyperhidrosis Disease Severity Scale

FIGURE 2

Change in the mean HDSS score (FAS). Data are expressed as mean ± SD. The number of patients evaluated was 80 included in the FAS from day 0 to day 14. **p < 0.001 (Wilcoxon signed‐rank test, versus. day 0). Abbreviations: FAS, full analysis set; HDSS, Hyperhidrosis Disease Severity Scale; SD, standard deviation

FIGURE 3

Kaplan–Meier curve of the cumulative achievement rate of patients with a HDSS score of 1 or 2 for a continuous 2 days (FAS). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2 days was 6 days (95% CI, 4–8 days). Abbreviations: CI, confidence interval; FAS, full analysis set; HDSS, Hyperhidrosis Disease Severity Scale

FIGURE 4

Mean DLQI total score on day 0 and day 14 (FAS). Data are expressed as mean ± SD. The number of patients evaluated was 80 included in the FAS on day 0 and day 14. **p < 0.001 (paired t‐test). Abbreviations: DLQI, Dermatology Life Quality Index; FAS, full analysis set; SD, standard deviation