TABLE 4.
Efficacy endpoints at EOT and EOS (PP population)
| ENDPOINT | EOT (N=166) | EOS (N=162) | ||
|---|---|---|---|---|
| OBSERVED VALUE | CHANGE FROM BASELINE | OBSERVED VALUE | CHANGE FROM BASELINE | |
| IGA mean score | 1.0 (1.0) | -3.2 (1.1) | 1.2 (1.0) | -3.0 (1.0) |
| Acne-QoL score | ||||
| Total | 101.8 (16.9) | 40.2 (27.9) | 103.3 (17.5) | 42.1 (29.8) |
| Self-perception | 26.8 (5.3) | 10.9 (8.8) | 27.5 (5.2) | 11.8 (8.8) |
| Role-emotional | 26.4 (5.3) | 10.8 (8.6) | 27.4 (5.1) | 11.9 (9.2) |
| Role-social | 22.2 (3.9) | 6.7 (7.1) | 22.7 (3.8) | 7.3 (7.5) |
| Acne symptoms | 26.5 (3.3) | 11.8 (6.0) | 25.8 (4.2) | 11.1 (6.8) |
| Lesion counts | ||||
| Total | 6.5 (9.8) | -70.5 (46.3) | 12.2 (17.8) | -63.7 (48.5) |
| Inflammatory | 2.8 (4.0) | -32.2 (16.2) | 5.7 (9.1) | -29.0 (16.0) |
| Noninflammatory | 3.7 (7.6) | -38.3 (42.0) | 6.6 (11.0) | -34.7 (43.0) |
| Nodular | 0.2 (0.8) | -6.8 (3.5) | 0.1 (0.6) | -6.9 (3.5) |
All values are presented as means (SDs).
Acne-QoL: Acne-specific Quality-of-life questionnaire; EOS: end of study; EOT: end of treatment; IGA: Investigator’s Global Assessment, PP: per protocol, SD: standard deviation