TABLE 3.
Efficacy analyses at Week 12 (intent-to-treat population; N=4,340)
| PARAMETER | DAPSONE GEL, 7.5% (N=2,162) | VEHICLE (N=2,178) | p VALUE |
|---|---|---|---|
| PRIMARY END POINTS | |||
| GAAS SUCCESS* | |||
| Percent of patients (95% CI) | 29.8 (27.9, 31.8) | 21.1 (19.3, 22.8) | <0.001 |
| INFLAMMATORY LESION COUNT, CHANGE FROM BASELINE | |||
| LS mean (SE) | -15.8 (0.24) | -13.9 (0.24) | <0.001 |
| NONINFLAMMATORY LESION COUNT, CHANGE FROM BASELINE | |||
| LS mean (SE) | -20.7 (0.39) | -18.0 (0.39) | <0.001 |
| SECONDARY END POINTS | |||
| TOTAL LESION COUNT | |||
| LS mean absolute change from baseline (SE) | -36.5 (0.54) | -32.0 (0.53) | <0.001 |
| LS mean percentage change from baseline (SE) | -48.8 (0.69) | -42.8 (0.67) | <0.001 |
| INFLAMMATORY LESION COUNT | |||
| LS mean percentage change from baseline (SE) | -54.6 (0.79) | -48.1 (0.79) | <0.001 |
| NONINFLAMMATORY LESION COUNT | |||
| LS mean percentage change from baseline (SE) | -45.1 (0.83) | -39.4 (0.81) | <0.001 |
*
GAAS success was defined as a score of 0 (none) or 1 (minimal).
CI=confidence interval; GAAS=Global Acne Assessment Score; LS=least squares; SE=standard error