Glabellar Lines
Conditions
Interventions
Based upon randomization on Baseline Day 1, subjects will receive either AGN-151586 750 U or placebo administered as 5 intramuscular injections in the glabellar complex.
Sponsors
Yajima Yoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult, over 18 years of age, having moderate or severe GL at maximum frown (as assessed by the evaluating investigator and subject using the FWS-A at Screening and Baseline Day 1). The investigator and subject ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
Exclusion criteria
Exclusion criteria: Adult, over 18 years of age, having moderate or severe GL at maximum frown (as assessed by the evaluating investigator and subject using the FWS-A at Screening and Baseline Day 1). The investigator and subject ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 grade improvement from baseline on the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) according to investigator assessment of GL severity at maximum frown at Day 7 2 grade improvement from baseline on the FWS-A according to subject assessment of GL severity at maximum frown at Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 grade improvement from baseline on the FWS-A according to subject assessment of GL severity at maximum frown at Hour 24 2 grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown at Hour 24 Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 (overall satisfaction) for GL at Hour 24 | — |
Countries
China, Japan, Taiwan
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed