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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05129319 | Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD | EARLY_PHASE1 | COMPLETED | 30 | — | — | Dec 16, 2021 | Jun 15, 2023 | Feb 6, 2024 | 1 | United States |
Time to return to baseline Glabellar Line Scale (GLS) score at maximum frown, as assessed by the blinded evaluating investigator. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
| Arm | Type | Description |
|---|---|---|
| OLD (4 U per 0.1 mL) | ACTIVE_COMPARATOR | The total Jeuveau dose will be 20U divided into 5 injections. Each subject will receive a total of 0.5 mL of Jeuveau during the treatment. |
| COLD (4 U per 0.02 mL group) | ACTIVE_COMPARATOR | The total Jeuveau dose will be 20U divided into 5 injections. Each injection will receive a total of 0.1 mL of Jeuveau during the treatment. |
| Name | Type | Description |
|---|---|---|
| prabotulinumtoxinA | DRUG | Injection of glabellar rhytids |
Inclusion Criteria: * At least 18 years of age at the time of signing the informed consent. * Overtly healthy as determined by medical evaluation (includes: medical history, physical examination, and vital signs). * Subjects have moderate or severe dynamic glabellar lines on maximum frown as assess...