| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05152576 | A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines | PHASE2 | COMPLETED | 124 | — | — | Nov 29, 2021 | Sep 6, 2022 | Jul 16, 2025 | 8 | United States |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo will be injected into the forehead on Day 1. |
| OnabotulinumtoxinA X Dose A | EXPERIMENTAL | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| OnabotulinumtoxinA X Dose B | EXPERIMENTAL | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| OnabotulinumtoxinA X Dose C | EXPERIMENTAL | OnabotulinumtoxinA X will be injected into the forehead on Day 1. |
| Name | Type | Description |
|---|---|---|
| OnabotulinumtoxinA X | DRUG | Intramuscular Injection |
| Placebo | DRUG | Intramuscular Injection |
Inclusion Criteria: * Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines * Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation Exclusion Criteria: * History of known immun...