Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06411002 | Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines | PHASE2 | COMPLETED | 27 | — | — | Apr 8, 2024 | Feb 12, 2025 | Apr 4, 2025 | 1 | United States |
• The proportion of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS
• The proportion of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS
| Arm | Type | Description |
|---|---|---|
| Active Treatment (DAXXIFY) | EXPERIMENTAL | All subjects will receive DAXXIFY for injection as IM injections. |
| Name | Type | Description |
|---|---|---|
| DAXXIFY | DRUG | Intramuscular injection of daxibotulintoxinA-lanm |
Inclusion Criteria: 1. Be outpatient, male or female subjects, in good general health, 18 years of age or older 2. Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS 3. Have a score of moderate (2) or severe (3) FHL during maximum contraction as asse...