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 purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants. AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
Intramuscular Injections
Intramuscular Injections
Beijing Hospital /ID# 256084
Beijing, Beijing Municipality, China
Dermatology Hospital of Southern Medical University /ID# 256172
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871
Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 255936
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 255937
Nanjing, Jiangsu, China
Wuxi People's Hospital /ID# 256029
Wuxi, Jiangsu, China
Xianyang Hospital of Yan'an University /ID# 256774
Xianyang, Shaanxi, China
Huashan Hospital, Fudan University /ID# 255870
Shanghai, Shanghai Municipality, China
Zhejiang Provincial People's Hospital /ID# 256028
Hangzhou, Zhejiang, China
Tokyo Center Clinic /ID# 267380
Chuo-ku, Tokyo, Japan
...and 2 more locations
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Day 7
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Day 7
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to approximately Day 84
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown
Participant's assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Hour 24
Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Hour 24
Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL
The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 5 (satisfaction with the effect of treatment) can also be used as a stand-alone item.
Time frame: Hour 24
Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 4 (natural look) for GL
The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 4 (satisfaction with the natural look) can also be used as a stand-alone item.
Time frame: Day 7
Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL Over Time
The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 5 (satisfaction with the effect of treatment) can also be used as a stand-alone item.
Time frame: Baseline up to approximately Day 84
Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Participant Assessment of GL Severity at Maximum Frown
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 42
Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Investigator Assessment of GL Severity at Maximum Frown
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 42
Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown Over Time
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 42
Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown Over Time
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 42
Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 42
Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 42
Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 84
Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Baseline to Day 84
Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown
Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Hour 24
Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
Time frame: Hour 24
Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL
The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact. Total scores are transformed to a 0 to 100 scale, with higher scores indicating better psychosocial outcomes.
Time frame: Day 7
Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL
The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact.
Time frame: Day 7
Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL
The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact.
Time frame: Day 7
Percentage of Partcipatns who Achieve Patient-Reported Global Assessment of Change in GL Based on the Global Assessment of Change in Glabellar Lines (GAC-GL) Over Time
The GAC-GL Questionnaire is a 2-item measure that assesses the appearance of the participant's GL "now" in comparison with their perspective before treatment at rest and at maximum furrow. The response options are scored on a 7-point VDS ranging from Very much improved to Very much worse. Scores are unique for at rest and maximum contraction, and they are simply the responses to the items.
Time frame: Baseline up to approximately Day 84
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