Table 1.
Patient demographics and baseline disease characteristics
| ≥ 9 to ≤ 16 y | > 16 y | |||
|---|---|---|---|---|
| Vehicle n = 19 | GT n = 25 | Vehicle n = 215 | GT n = 438 | |
| Demographics | ||||
| Age (years) | ||||
| Mean (SD) | 14.1 (1.7) | 14.6 (1.4) | 35.1 (11.2) | 33.3 (10.5) |
| Median | 14.0 | 15.0 | 33.0 | 32.0 |
| Range | 9‐16 | 11‐16 | 17‐76 | 17‐65 |
| Sex, n (%) | ||||
| Male | 4 (21.1) | 5 (20.0) | 110 (51.2) | 207 (47.3) |
| Female | 15 (78.9) | 20 (80.0) | 105 (48.8) | 231 (52.7) |
| White, n (%) | 17 (89.5) | 18 (72.0) | 179 (83.3) | 356 (81.3) |
| Weight (kg) | ||||
| Mean (SD) | 64.8 (15.8) | 71.9 (15.7) | 84.3 (19.0) | 81.6 (19.3) |
| Median | 62.6 | 72.3 | 83.0 | 79.8 |
| Range | 47.2‐117.9 | 47.2‐107.7 | 45.8‐145.1 | 46.9‐149.7 |
| BMI (kg/m2), mean (SD) | 24.0 (5.2) | 26.3 (5.6) | 28.1 (5.1) | 27.5 (5.4) |
| Baseline disease characteristics | ||||
| Years with axillary hyperhidrosis, mean (SD) | 4.6 (3.6) | 4.4 (4.1) | 17.0 (10.5) | 15.9 (10.8) |
| Sweat production (mg/5 min),a mean (SD) | 151.7 (150.6) | 145.8 (133.4) | 178.4 (163.0) | 174.0 (219.5) |
| ASDD/ASDD‐C Item 2 (sweating severity), mean (SD) | 6.7 (1.7) | 7.5 (1.2) | 7.2 (1.6) | 7.3 (1.6) |
| HDSS, n (%) | ||||
| Grade 3 | 14 (73.7) | 15 (60.0) | 141 (65.6) | 262 (59.8) |
| Grade 4 | 5 (26.3) | 10 (40.0) | 73 (34.0) | 176 (40.2) |
| DLQI,b mean (SD) | NAc | NAc | 10.6 (5.9) | 11.9 (6.1) |
| CDLQI, mean (SD) | 8.5 (5.6) | 9.9 (5.5) | NAc | NAc |
Intent‐to‐treat population.
ASDD, axillary sweating daily diary; ASDD‐C, ASDD‐Children; BMI, body mass index; CDLQI, children's DLQI; DLQI, dermatology life quality index; GT, topical glycopyrronium tosylate; HDSS, Hyperhidrosis Disease Severity Scale; NA, not applicable; SD, standard deviation.
a
Gravimetrically measured average from the left and right axillae.
b
n = 24 for GT group ≥ 9 to ≤ 16 y of age.
c
Patients ≥ 9 to ≤ 16 y of age were administered the CDLQI and patients > 16 y of age were administered the DLQI.