Table 3.
Summary of secondary efficacy end‐points
| Secondary efficacy end‐points | Sofpironium (n = 141) | Vehicle (n = 140) | P |
|---|---|---|---|
| Patients with HDSS 1 or 2 at week 6, n (%) | 85 (60.3%) | 67 (47.9%) | 0.036* |
| Patients with ≥50% reduction in total gravimetric weight of sweat at week 6/at baseline, n (%) | 109 (77.3%) | 93 (66.4%) | 0.042* |
| Mean change in total gravimetric weight of sweat from baseline to week 6 (SD) | –157.6 mg (149.32) | –127.6 mg (121.05) | － |
| Least squares mean | –157.1 mg | –128.1 mg | 0.015 † |
| Mean change in DLQI score from baseline to week 6 (SD) | –6.8 (4.94) | –4.5 (4.54) | <0.001 ‡ |
| Patients with improvement ≥1.5 in HDSM‐Ax score from baseline to week 6, n (%) | 68 (48.2%) | 37 (26.4%) | <0.001* |
| Mean change in HDSM‐Ax score from baseline to week 6 (SD) | –1.41 (1.008) | –0.93 (0.902) | <0.001 ‡ |
BMI, body mass index; DLQI, Dermatology Life Quality Index; HDSM‐Ax, Hyperhidrosis Disease Severity Measure–Axillary; HDSS, Hyperhidrosis Disease Severity Score; SD, standard deviation.
*
χ2‐Test.
†
ancova adjusting with baseline value.
‡
Unpaired t‐test.