Table 3.
Summary of least square mean changes from baseline in efficacy parameters
| Baseline | Change from baseline | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | |||||||||
| Mean (SD) | n | LS mean (SE) | n | P | LS mean (SE) | n | P | LS mean (SE) | n | P | |
| IGA | |||||||||||
| OPA‐15406 0.3% | 2.8 (0.4) | 24 | −0.50 (0.14) | 24 | 0.0483 | −1.13 (0.19) | 24 | 0.0002 | −1.04 (0.22) | 23 | 0.0048 |
| OPA‐15406 1% | 2.8 (0.4) | 25 | −0.70 (0.14) | 25 | 0.0033 | −1.04 (0.19) | 24 | 0.0006 | −1.16 (0.21) | 24 | 0.0014 |
| Vehicle | 2.9 (0.3) | 24 | −0.10 (0.14) | 24 | −0.06 (0.20) | 21 | −0.12 (0.23) | 18 | |||
| EASI | |||||||||||
| OPA‐15406 0.3% | 12.07 (6.79) | 24 | −4.61 (0.93) | 24 | 0.0023 | −6.68 (1.10) | 24 | <0.0001 | −5.33 (1.28) | 23 | 0.0027 |
| OPA‐15406 1% | 9.37 (5.80) | 25 | −2.99 (0.91) | 25 | 0.0539 | −5.06 (1.09) | 24 | 0.0005 | −5.52 (1.26) | 24 | 0.0019 |
| Vehicle | 10.31 (5.92) | 24 | −0.45 (0.92) | 24 | 0.66 (1.13) | 21 | 0.56 (1.36) | 18 | |||
| VAS pruritus | |||||||||||
| OPA‐15406 0.3% | 54.8 (17.9) | 17 | −18.61 (6.50) | 17 | 0.0447 | −16.79 (5.94) | 17 | 0.2564 | −18.00 (7.27) | 16 | 0.0167 |
| OPA‐15406 1% | 45.6 (29.0) | 17 | −12.83 (6.47) | 17 | 0.1557 | −24.27 (6.01) | 16 | 0.0488 | −17.21 (7.29) | 16 | 0.0198 |
| Vehicle | 46.8 (28.9) | 17 | 0.34 (6.46) | 17 | −6.95 (6.11) | 15 | 8.19 (7.58) | 14 | |||
| POEM | |||||||||||
| OPA‐15406 0.3% | 11.4 (5.2) | 24 | −4.50 (0.82) | 24 | <0.0001 | −5.67 (0.97) | 24 | <0.0001 | −4.33 (1.16) | 23 | 0.0003 |
| OPA‐15406 1% | 11.2 (5.0) | 25 | −4.94 (0.81) | 25 | <0.0001 | −5.13 (0.96) | 24 | <0.0001 | −4.37 (1.14) | 24 | 0.0002 |
| Vehicle | 13.0 (7.5) | 24 | 0.36 (0.83) | 24 | 0.98 (1.01) | 21 | 2.26 (1.24) | 18 | |||
| Affected BSA† | |||||||||||
| OPA‐15406 0.3% | 21.13 (9.56) | 24 | −4.08 (1.66) | 24 | 0.1219 | −7.72 (1.88) | 24 | 0.0004 | −6.06 (2.36) | 23 | 0.0274 |
| OPA‐15406 1% | 15.96 (8.60) | 25 | −4.19 (1.62) | 25 | 0.1036 | −6.81 (1.85) | 24 | 0.0010 | −8.21 (2.32) | 24 | 0.0050 |
| Vehicle | 17.46 (8.65) | 24 | −0.42 (1.63) | 24 | 2.37 (1.92) | 21 | 1.78 (2.53) | 18 | |||
†
Data on LS mean change from baseline in the percentage of affected BSA. BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator Global Assessment; LS, least square; POEM, Patient‐Oriented Eczema Measure; SD, standard deviation; SE, standard error; VAS, Visual Analog Scale.