Forehead Lines
Conditions
Interventions
In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles.
Group 1: Participants will receive onabotulinumto
Sponsors
Yajima Yoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment. Glabellar lines (GL) of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment. Good health as per the investigator's judgment based on medical history, abbreviated physical examination and vital sign measurements, including no known active pandemic infection (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]).
Exclusion criteria
Exclusion criteria: FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1 prior to study treatment. History of known immunization or hypersensitivity to any botulinum neurotoxin serotype. History of treatments to the mid or upper face.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of Participants who Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS- A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction [Time Frame: Day 30] 2.Number of Participants with Adverse Events (AEs) Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3.Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity [Time Frame: Day 30] 4.Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Maximum Contraction [Time Frame: Day 30] 5.Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Rest For participants rated as at least mild at baseline [Time Frame: Day 30] 6.Time to Return to at least 'Moderate' for the Participants who Achieve Investigator FWS-A ratings of 'None' or 'Mild' on FHL Severity at Maximum Contraction [Time Frame: Day 30] 7.Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ) [Time Frame: Day 60] 8.Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ [Time Frame: Day 30] 9.Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale [Time Frame: Day 30] 10.Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit [Time Frame: Day 30] | — |
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed