Forehead Lines
Conditions
Keywords
Forehead Lines, AGN-151586, TrenibotulinumtoxinE
Brief summary
The objective of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of moderate to severe forehead lines (FHL) in adult participants.
Interventions
DRUGAGN-151586
Injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must have moderate (Grade 2) or severe (Grade 3) forehead lines (FHL) at maximum eyebrow elevation as assessed by the subject and investigator using Forehead Lines Severity Scale (FHLSS) at Screening visit and Baseline Day 1 visit. * Participant must have moderate (Grade 2) or severe (Grade 3) glabellar lines (GL) at maximum frown as assessed by the subject and investigator using Allergan Glabellar Lines Severity Scale (AGLSS) at Screening visit and Baseline Day 1 visit. * Sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their FHL and GL in investigator's opinion.
Exclusion criteria
* Clinically relevant or significant ECG abnormalities. * Active infection or dermatological condition at any of the treatment injection sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Approximately 42 Days | 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. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed