Glabellar Lines
Conditions
Keywords
Glabellar Lines, AGN-151586
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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study was to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL. This was a 12-week study in which eligible subjects were enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants were randomly assigned to receive AGN-151586 or placebo. There was 1 in a 4 chance that participants would receive placebo. Around 600 adult participants with moderate to severe GL were to be enrolled in the study in approximately 38 sites across the world. Participants received either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may have received an open-label treatment of AGN-151586 during the study. Participants attended regular visits during the study at a study site. The effect of the treatment was checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.
Interventions
DRUGPlacebo
Placebo solution for injection
DRUGAGN-151586
AGN-151586 solution for injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable). * Participant must have moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline Day 1 visit.
Exclusion criteria
* Uncontrolled systemic disease. * Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including: * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function * History of facial nerve palsy * Infection or dermatological condition at the treatment injection sites * Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart * Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator * History of known immunization to any botulinum neurotoxin serotype. * Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to Baseline (Day 1 of treatment) and for therapeutic treatment within the last 12 months prior to study drug administration. * 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 participant 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 or 5 half-lives of the drug (whichever is longer) 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA] | Baseline, Day 7 (Double-blind period) | \[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies] | Baseline, Day 7 (Double-blind period) | \[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies] | Baseline, Day 7 (Double-blind Period) | \[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Number of Participants With Adverse Events | From time of informed consent to end of study; median time on follow-up was 85 days for Double-blind Placebo, AGN-151586, Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for Placebo/None group, and 53 days for AGN-151586/None group | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA] | Hour 24 (Double-blind Period) | \[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA] | Day 7 (Double-blind Period) | \[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies] | Baseline, Day 7 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | Baseline, Hour 24 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | Baseline, Hour 24 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 during the Double-Blind Period are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | Baseline, Hour 24 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | Baseline, Hour 24 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [European Union Regulatory Agencies] | Hour 24 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies] | Day 7 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period) | \[Secondary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Time to the First ≥1-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies] | From Baseline to Day 43 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Time to the first ≥1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown is reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who did not improve at least 1 grade from Baseline, censoring occurred at the latest visit during the treatment period for which FWS data were available. |
| Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period) | \[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period) | \[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Time to Return to Baseline FWS According to Participant Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies] | From Baseline to Day 43 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Time to return to Baseline (Baseline criterion of Moderate or Severe) on the Facial Wrinkle Scale (FWS) according to participant assessment of FWS at maximum frown after achieving responder definition on Day 7 is reported. Responder definition was a rating of None or Mild on the FWS. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who maintained their response, censoring occurred at the latest visit during the treatment period for which FWS was available. |
| Time to Return to Baseline FWS According to Investigator Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies] | From Baseline to Day 43 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Time to return to Baseline (Baseline criterion of Moderate or Severe) on the Facial Wrinkle Scale (FWS) according to investigator assessment of FWS at maximum frown after achieving responder definition on Day 7 is reported. Responder definition was a rating of None or Mild on the FWS. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who maintained their response, censoring occurred at the latest visit during the treatment period for which FWS was available. |
| Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Baseline, Hours 8, 24, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies] | Baseline, Day 7 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 10 (Look Angry). Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies] | Baseline, Day 7 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 5 (Look Less Attractive). Percentages are rounded off to nearest single decimal. |
| Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Hours 24 and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] The GAC-GL Questionnaire assesses the appearance of the participant's GL now in comparison with their perspective before treatment. Participants assessed the change in their glabellar lines at maximum frown using a 7-point verbal descriptor scale (VDS): very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse, ranging from 3 to -3. Positive changes indicate improvement, 0 no change, and negative changes indicate worsening. |
| Time to the First ≥ 1-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies] | From Baseline to Day 43 (Double-blind Period) | \[Secondary endpoint for European Union regulatory agencies\] Time to the first ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown is reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who did not improve at least 1 grade from Baseline, censoring occurred at the latest visit during the treatment period for which FWS data were available. |
| Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period) | \[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period) | \[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal. |
| Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA] | Day 7 (Double-blind Period) | \[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal. |
Countries
Canada, Germany, Hungary, Poland, United States
Participant flow
Pre-assignment details
A total of 638 participants with moderate to severe glabellar lines (GL) at maximum frown were enrolled and randomized in a 3:1 ratio to receive either AGN-151586 or placebo in the Double-blind Period. For those meeting all the retreatment criteria on Day 43, a single open-label treatment with AGN-151586 was administered on the same day.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43. | 156 |
| AGN-151586 Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43. | 482 |
| Total | 638 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Double-blind Period | Lost to Follow-up | 0 | 3 | 0 | 0 | 0 | 0 |
| Double-blind Period | Other, not specified | 3 | 8 | 0 | 0 | 0 | 0 |
| Double-blind Period | Withdrawal by Subject | 5 | 14 | 0 | 0 | 0 | 0 |
| Double-blind Period | Withdrawal by Subject due to Adverse Event | 0 | 3 | 0 | 0 | 0 | 0 |
| Open-label Period | COVID-19 Infection | 0 | 0 | 0 | 0 | 1 | 0 |
| Open-label Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 5 | 2 |
| Open-label Period | Other, not specified | 0 | 0 | 0 | 0 | 4 | 0 |
| Open-label Period | Withdrawal by Subject | 0 | 0 | 3 | 1 | 7 | 9 |
| Open-label Period | Withdrawal by Subject due to Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | AGN-151586 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 12.75 | 47.2 years STANDARD_DEVIATION 12.68 | 47.6 years STANDARD_DEVIATION 12.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants | 63 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 433 Participants | 575 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 0 = None | 0 Participants | 0 Participants | 0 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 1 = Mild | 2 Participants | 3 Participants | 1 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 2 = Moderate | 149 Participants | 190 Participants | 41 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 3 = Severe | 331 Participants | 445 Participants | 114 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 0 = None | 0 Participants | 0 Participants | 0 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 1 = Mild | 3 Participants | 4 Participants | 1 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 2 = Moderate | 149 Participants | 190 Participants | 41 Participants |
| Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 3 = Severe | 330 Participants | 444 Participants | 114 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 19 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 26 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 14 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 432 Participants | 574 Participants | 142 Participants |
| Sex: Female, Male Female | 429 Participants | 566 Participants | 137 Participants |
| Sex: Female, Male Male | 53 Participants | 72 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 156 | 0 / 482 | 0 / 3 | 0 / 145 | 0 / 17 | 0 / 437 |
| other Total, other adverse events | 9 / 156 | 31 / 482 | 0 / 3 | 8 / 145 | 0 / 17 | 14 / 437 |
| serious Total, serious adverse events | 1 / 156 | 3 / 482 | 0 / 3 | 0 / 145 | 0 / 17 | 1 / 437 |
Outcome results
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: From time of informed consent to end of study; median time on follow-up was 85 days for Double-blind Placebo, AGN-151586, Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for Placebo/None group, and 53 days for AGN-151586/None group
Population: Safety population: all participants who were treated with at least 1 dose of study drug. All safety analyses were performed with participants analyzed by their actual treatment received in the DB period/OL period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events | Any TEAE | 44 participants |
| Placebo | Number of Participants With Adverse Events | TESAE | 1 participants |
| AGN-151586 | Number of Participants With Adverse Events | Any TEAE | 118 participants |
| AGN-151586 | Number of Participants With Adverse Events | TESAE | 3 participants |
| Placebo/None | Number of Participants With Adverse Events | Any TEAE | 0 participants |
| Placebo/None | Number of Participants With Adverse Events | TESAE | 0 participants |
| Placebo/AGN-151586 | Number of Participants With Adverse Events | Any TEAE | 32 participants |
| Placebo/AGN-151586 | Number of Participants With Adverse Events | TESAE | 0 participants |
| AGN-151586/None | Number of Participants With Adverse Events | Any TEAE | 0 participants |
| AGN-151586/None | Number of Participants With Adverse Events | TESAE | 0 participants |
| AGN-151586/AGN-151586 | Number of Participants With Adverse Events | Any TEAE | 90 participants |
| AGN-151586/AGN-151586 | Number of Participants With Adverse Events | TESAE | 1 participants |
Primary
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]
\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies] | 0.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies] | 72.1 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [66.5, 76.2]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]
\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Day 7 (Double-blind period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies] | 0.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies] | 61.0 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [54.9, 65.4]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]
\[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Day 7 (Double-blind period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA] | 0.6 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA] | 60.0 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [54.7, 63.9]Cochran-Mantel-Haenszel
Secondary
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The GAC-GL Questionnaire assesses the appearance of the participant's GL now in comparison with their perspective before treatment. Participants assessed the change in their glabellar lines at maximum frown using a 7-point verbal descriptor scale (VDS): very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse, ranging from 3 to -3. Positive changes indicate improvement, 0 no change, and negative changes indicate worsening.
Time frame: Hours 24 and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 24 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 48 | 0.1 units on a scale | Standard Error 0.09 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 7 | 0.1 units on a scale | Standard Error 0.08 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 14 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 21 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 28 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 35 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 43 | 0.1 units on a scale | Standard Error 0.09 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 43 | 0.0 units on a scale | Standard Error 0.06 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 24 | 1.4 units on a scale | Standard Error 0.07 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 21 | 0.5 units on a scale | Standard Error 0.07 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 48 | 1.9 units on a scale | Standard Error 0.06 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 35 | 0.0 units on a scale | Standard Error 0.07 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 7 | 2.2 units on a scale | Standard Error 0.06 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 28 | 0.2 units on a scale | Standard Error 0.07 |
| AGN-151586 | Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 14 | 1.5 units on a scale | Standard Error 0.07 |
Secondary
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 36 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 14 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 24 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 21 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 48 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 12 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 35 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 7 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 43 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 8 | 1.5 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 43 | 0.0 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 8 | 10.9 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 12 | 18.6 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 24 | 36.5 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 36 | 53.3 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 48 | 61.7 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 7 | 72.1 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 14 | 32.8 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 21 | 5.4 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 28 | 1.1 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 35 | 0.3 percentage of participants |
Secondary
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 36 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 14 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 24 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 21 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 48 | 2.3 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 12 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 35 | 1.5 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 7 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 43 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 8 | 0.0 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 43 | 0.8 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 8 | 7.6 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 12 | 17.7 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 24 | 30.9 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 36 | 44.0 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Hour 48 | 50.1 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 7 | 61.0 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 14 | 30.5 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 21 | 4.6 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 28 | 1.9 percentage of participants |
| AGN-151586 | Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] | Day 35 | 1.4 percentage of participants |
Secondary
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hour 24 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 13.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 72.5 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [51.1, 66.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hour 24 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 11.5 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 64.1 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [45.2, 60]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50 were included. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies] | 8.5 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies] | 66.6 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [51.3, 65]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 during the Double-Blind Period are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hour 24 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 0.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 36.5 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [30.5, 40.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hour 24 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 0.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies] | 30.9 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [25.2, 35.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 10 (Look Angry). Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, and a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants with a score that could improve at least 4 points from Baseline were included. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies] | 5.6 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies] | 54.5 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [42.2, 55.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 5 (Look Less Attractive). Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, and a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants with a score that could improve at least 4 points from Baseline were included. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies] | 3.9 percentage of participants |
| AGN-151586 | Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies] | 48.1 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [38, 50.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Time frame: Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies] | 7.7 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies] | 77.7 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [63.7, 76.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA]
\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Time frame: Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA] | 9.0 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA] | 78.5 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [63.7, 75.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA]
\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Time frame: Day 7 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA] | 5.1 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA] | 77.6 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [67.4, 77.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Time frame: Hour 24 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [European Union Regulatory Agencies] | 16.2 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [European Union Regulatory Agencies] | 58.7 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [34.4, 50.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA]
\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Time frame: Hour 24 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA] | 17.3 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA] | 59.2 percentage of participants |
Comparison: AGN-151586 vs Placebop-value: <0.000195% CI: [34.5, 49.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hours 8, 24, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Hour 24 | 16.2 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 21 | 2.5 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 7 | 4.6 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 28 | 4.7 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Hour 48 | 8.5 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 35 | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 14 | 5.8 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 43 | 4.8 percentage of participants |
| Placebo | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Hour 8 | 14.3 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 43 | 58.1 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Hour 8 | 33.1 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Hour 24 | 58.7 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Hour 48 | 71.4 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 7 | 76.9 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 14 | 69.9 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 21 | 61.4 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 28 | 56.1 percentage of participants |
| AGN-151586 | Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] | Day 35 | 58.3 percentage of participants |
Secondary
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
\[Secondary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 36 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 14 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 24 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 21 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 48 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 12 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 35 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 7 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 43 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 8 | 0.0 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 43 | 0.0 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 8 | 7.1 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 12 | 15.9 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 24 | 30.4 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 36 | 43.2 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 48 | 50.1 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 7 | 60.0 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 14 | 25.3 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 21 | 2.7 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 28 | 0.2 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 35 | 0.4 percentage of participants |
Secondary
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
\[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 36 | 0.7 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 14 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 24 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 21 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 48 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 12 | 0.7 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 35 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 7 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 43 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 8 | 1.3 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 43 | 0.0 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 8 | 11.0 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 12 | 20.2 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 24 | 37.4 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 36 | 53.1 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 48 | 62.2 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 7 | 72.6 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 14 | 32.3 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 21 | 5.2 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 28 | 1.3 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 35 | 0.4 percentage of participants |
Secondary
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA]
\[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Time frame: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 36 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 14 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 24 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 21 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 48 | 1.9 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 12 | 0.7 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 35 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 7 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 43 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 8 | 0.0 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 43 | 0.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 8 | 8.1 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 12 | 18.5 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 24 | 32.1 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 36 | 44.4 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Hour 48 | 51.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 7 | 63.3 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 14 | 29.8 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 21 | 4.2 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 28 | 1.9 percentage of participants |
| AGN-151586 | Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] | Day 35 | 1.2 percentage of participants |
Secondary
Time to Return to Baseline FWS According to Investigator Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Time to return to Baseline (Baseline criterion of Moderate or Severe) on the Facial Wrinkle Scale (FWS) according to investigator assessment of FWS at maximum frown after achieving responder definition on Day 7 is reported. Responder definition was a rating of None or Mild on the FWS. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who maintained their response, censoring occurred at the latest visit during the treatment period for which FWS was available.
Time frame: From Baseline to Day 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants who did not meet the responder definition on Day 7 were excluded from the analysis; analysis was limited to those that responded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Return to Baseline FWS According to Investigator Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies] | 15.0 days |
| AGN-151586 | Time to Return to Baseline FWS According to Investigator Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies] | 21.0 days |
Secondary
Time to Return to Baseline FWS According to Participant Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Time to return to Baseline (Baseline criterion of Moderate or Severe) on the Facial Wrinkle Scale (FWS) according to participant assessment of FWS at maximum frown after achieving responder definition on Day 7 is reported. Responder definition was a rating of None or Mild on the FWS. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who maintained their response, censoring occurred at the latest visit during the treatment period for which FWS was available.
Time frame: From Baseline to Day 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants who did not meet the responder definition on Day 7 were excluded from the analysis; analysis was limited to those that responded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Return to Baseline FWS According to Participant Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies] | 28.0 days |
| AGN-151586 | Time to Return to Baseline FWS According to Participant Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies] | 21.0 days |
Secondary
Time to the First ≥1-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Time to the first ≥1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown is reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who did not improve at least 1 grade from Baseline, censoring occurred at the latest visit during the treatment period for which FWS data were available.
Time frame: From Baseline to Day 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to the First ≥1-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies] | 41.0 days |
| AGN-151586 | Time to the First ≥1-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies] | 0.7 days |
Secondary
Time to the First ≥ 1-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies]
\[Secondary endpoint for European Union regulatory agencies\] Time to the first ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown is reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who did not improve at least 1 grade from Baseline, censoring occurred at the latest visit during the treatment period for which FWS data were available.
Time frame: From Baseline to Day 43 (Double-blind Period)
Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to the First ≥ 1-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies] | 41.9 days |
| AGN-151586 | Time to the First ≥ 1-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies] | 1.0 days |