| Composite primary endpoint (ITT population) . | Study 001 n = 234 . | Study 005 n = 415 . | |||
|---|---|---|---|---|---|
| Placebo n = 80 . | NivobotulinumtoxinA 20 U (GL) n = 154 . | Placebo n = 82 . | NivobotulinumtoxinA 20 U (GL) n = 173 . | NivobotulinumtoxinA 44 U (GL + LCL) n = 160 . | |
| Responder, n (%) | 0 | 71 (46.1) | 0 | 78 (45.1) | 66 (41.3) |
| P value | — | <.001 | — | <.001 | <.001 |
| Coprimary endpoint (mITT population) | Placebo n = 68 | NivobotulinumtoxinA 20 U (GL) n = 123 | Placebo n = 67 | NivobotulinumtoxinA 20 U (GL) n = 155 | NivobotulinumtoxinA 44 U (GL + LCL) n = 134 |
| Investigator FWS | |||||
| Responder, n (%) | 3 (4.4) | 95 (77.2) | 3 (4.5) | 115 (74.2) | 99 (73.9) |
| P value | <.001 | <.001 | <.001 | ||
| Participant FWS | |||||
| Responder, n (%) | 3 (4.4) | 80 (65.0) | 2 (3.0) | 107 (69.0) | 82 (61.2) |
| P value | <.001 | <.001 | <.001 | ||
| Composite primary endpoint (ITT population) . | Study 001 n = 234 . | Study 005 n = 415 . | |||
|---|---|---|---|---|---|
| Placebo n = 80 . | NivobotulinumtoxinA 20 U (GL) n = 154 . | Placebo n = 82 . | NivobotulinumtoxinA 20 U (GL) n = 173 . | NivobotulinumtoxinA 44 U (GL + LCL) n = 160 . | |
| Responder, n (%) | 0 | 71 (46.1) | 0 | 78 (45.1) | 66 (41.3) |
| P value | — | <.001 | — | <.001 | <.001 |
| Coprimary endpoint (mITT population) | Placebo n = 68 | NivobotulinumtoxinA 20 U (GL) n = 123 | Placebo n = 67 | NivobotulinumtoxinA 20 U (GL) n = 155 | NivobotulinumtoxinA 44 U (GL + LCL) n = 134 |
| Investigator FWS | |||||
| Responder, n (%) | 3 (4.4) | 95 (77.2) | 3 (4.5) | 115 (74.2) | 99 (73.9) |
| P value | <.001 | <.001 | <.001 | ||
| Participant FWS | |||||
| Responder, n (%) | 3 (4.4) | 80 (65.0) | 2 (3.0) | 107 (69.0) | 82 (61.2) |
| P value | <.001 | <.001 | <.001 | ||
The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement in FWS from baseline according to investigator and participant assessment of GL severity at maximum frown in the ITT population at Day 30. The coprimary endpoint was the proportion of participants who had GL severity at maximum smile of “none or mild” based on investigator and participant FWS ratings in the mITT population at Day 30. FWS, facial wrinkle scale; GL, glabellar lines; ITT, intention-to-treat; LCL, lateral canthal lines; mITT, modified intention-to-treat.
| Composite primary endpoint (ITT population) . | Study 001 n = 234 . | Study 005 n = 415 . | |||
|---|---|---|---|---|---|
| Placebo n = 80 . | NivobotulinumtoxinA 20 U (GL) n = 154 . | Placebo n = 82 . | NivobotulinumtoxinA 20 U (GL) n = 173 . | NivobotulinumtoxinA 44 U (GL + LCL) n = 160 . | |
| Responder, n (%) | 0 | 71 (46.1) | 0 | 78 (45.1) | 66 (41.3) |
| P value | — | <.001 | — | <.001 | <.001 |
| Coprimary endpoint (mITT population) | Placebo n = 68 | NivobotulinumtoxinA 20 U (GL) n = 123 | Placebo n = 67 | NivobotulinumtoxinA 20 U (GL) n = 155 | NivobotulinumtoxinA 44 U (GL + LCL) n = 134 |
| Investigator FWS | |||||
| Responder, n (%) | 3 (4.4) | 95 (77.2) | 3 (4.5) | 115 (74.2) | 99 (73.9) |
| P value | <.001 | <.001 | <.001 | ||
| Participant FWS | |||||
| Responder, n (%) | 3 (4.4) | 80 (65.0) | 2 (3.0) | 107 (69.0) | 82 (61.2) |
| P value | <.001 | <.001 | <.001 | ||
| Composite primary endpoint (ITT population) . | Study 001 n = 234 . | Study 005 n = 415 . | |||
|---|---|---|---|---|---|
| Placebo n = 80 . | NivobotulinumtoxinA 20 U (GL) n = 154 . | Placebo n = 82 . | NivobotulinumtoxinA 20 U (GL) n = 173 . | NivobotulinumtoxinA 44 U (GL + LCL) n = 160 . | |
| Responder, n (%) | 0 | 71 (46.1) | 0 | 78 (45.1) | 66 (41.3) |
| P value | — | <.001 | — | <.001 | <.001 |
| Coprimary endpoint (mITT population) | Placebo n = 68 | NivobotulinumtoxinA 20 U (GL) n = 123 | Placebo n = 67 | NivobotulinumtoxinA 20 U (GL) n = 155 | NivobotulinumtoxinA 44 U (GL + LCL) n = 134 |
| Investigator FWS | |||||
| Responder, n (%) | 3 (4.4) | 95 (77.2) | 3 (4.5) | 115 (74.2) | 99 (73.9) |
| P value | <.001 | <.001 | <.001 | ||
| Participant FWS | |||||
| Responder, n (%) | 3 (4.4) | 80 (65.0) | 2 (3.0) | 107 (69.0) | 82 (61.2) |
| P value | <.001 | <.001 | <.001 | ||
The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement in FWS from baseline according to investigator and participant assessment of GL severity at maximum frown in the ITT population at Day 30. The coprimary endpoint was the proportion of participants who had GL severity at maximum smile of “none or mild” based on investigator and participant FWS ratings in the mITT population at Day 30. FWS, facial wrinkle scale; GL, glabellar lines; ITT, intention-to-treat; LCL, lateral canthal lines; mITT, modified intention-to-treat.
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