Table 2.
Summary of Mean Maximal Dermal Assessment Scores of the Safety Population
| Methylphenidate Transdermal System (MTS) |
||||||||||
| 10 mg/12.5 cm2 (n = 305) |
15 mg/18.75 cm2 (n = 260) |
20 mg/25 cm2 (n = 174) |
30 mg/37.5 cm2 (n = 93) |
Overall (N = 305) |
||||||
| Dermal Assessment | Currenta | Priorb | Current | Prior | Current | Prior | Current | Prior | Current | Prior |
| Dermal Response Scale, mean (± SD)c | 0.9 (0.8) | 0.3 (0.5) | 1.0 (0.8) | 0.4 (0.7) | 1.2 (0.9) | 0.4 (0.6) | 1.2 (0.9) | 0.5 (0.7) | 1.4 (0.8) | 0.8 (0.8) |
| n | 296 | 296 | 260 | 260 | 170 | 170 | 92 | 92 | 303 | 303 |
| Experience of Discomfort Scale, mean (± SD)d | 0.2 (0.4) | 0.1 (0.4) | 0.3 (0.5) | 0.2 (0.4) | 0.3 (0.6) | 0.2 (0.5) | 0.5 (0.6) | 0.3 (0.5) | 0.6 (0.8) | 0.4 (0.6) |
| n | 295 | 295 | 260 | 260 | 170 | 170 | 92 | 92 | 303 | 303 |
| Transdermal System Adherence Scale, mean (± SD)e | 0.5 (0.9) | 0.5 (0.9) | 0.4 (0.7) | 0.5 (0.7) | 0.9 (1.1) | |||||
| n | 224 | 203 | 130 | 79 | 272 | |||||
Current = MTS patch site at time of assessment. Note: MTS patch was clear, allowing for visual assessment.
Prior = previous day's treatment site.
0: no evidence of irritation; 1: minimal erythema; 2: definite erythema; 3: erythema and papules; 4: definite edema; 5: erythema, edema, and papules; 6: vesicular eruption; and 7: strong reaction beyond test site.
0: no discomfort; 1: mild discomfort; 2: moderate, but tolerable discomfort; and 3: severe, intolerable discomfort.
0: ≥ 90%, 1: ≥ 75% to < 90%, 2: ≥ 50% to < 75%, 3: < 50%, and 4: patch detached.