Status:
COMPLETED
Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines
Lead Sponsor:
AbbVie
Conditions:
Moderate to Severe Glabellar Lines
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The p...
Eligibility Criteria
Inclusion
- Participants must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
- Participants must have moderate or severe GL at maximum frown as assessed by the investigator using the FWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.
Exclusion
- Participants must not have uncontrolled systemic disease.
- History of known immunization to any botulinum neurotoxin serotype
- Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
- Anticipated need for surgery or overnight hospitalization during the study.
- History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
- History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
- Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06151561
Start Date
January 5 2024
End Date
April 3 2024
Last Update
April 4 2024
Active Locations (1)
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1
Tokyo Center Clinic /ID# 257898
Central District, Tokyo, Japan, 103-0028