Glabellar Lines
Conditions
Brief summary
The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.
Detailed description
This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 participants who were to complete former studies in this program (370 participants from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 participants from studies MRZ 60201-0724/1 (10) and MRZ 60201-0741/1) (11) were expected to enroll in this study in 26 centers in the United States, Canada and Germany. Participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four feeder studies in the frown line program were eligible to participate in this repeated dose study. Each participant received a dose of 20 units incobotulinumtoxinA (Xeomin) intramuscular injection on Visit 1 (Day 0 of Cycle 1). Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles (one cycle \>= 85 days). Intervals between treatments were at least three months or 12 weeks, i.e., \>= 85 days. For a new treatment cycle to start, the participant had to request a re-injection. The investigator then had to assess if the glabellar frown lines had relapsed to 'moderate' or 'severe'. In this case, a new injection could be administered. The treatment duration per participant was 24 months and up to eight cycles for participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 and 6 months and up to two cycles for participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1, respectively. Participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 participated at least one year in the study whereas participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1 participated for six months and up to two cycles.
Interventions
Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program
Exclusion criteria
Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Baseline up to Month 30 | — |
| Incidence of Adverse Events of Special Interest (AESI) | Baseline up to Month 30 | — |
| Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | FWS was used to assess the severity of glabellar frown lines at maximum frown by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1). |
| Percentage of Responders at Rest as Assessed by the Investigator According to FWS | At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | FWS was used to assess the severity of glabellar frown lines at rest by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1). Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1). |
| Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | Participant's assessment of the glabellar frown lines at maximum frown on the 4-point scale was done by asking participant the following question in local language: How would you judge the potency of frown muscle action by comparison to sample photos at this visit? The possible rating responses were: 0 = no muscle action at all, 1 = some even slight muscle action possible, 2 = moderately strong muscle action possible, 3 = strong muscle action possible which may cause local pallor. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score. |
| Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | Participant's assessment of the glabellar frown lines at rest on the 4-point scale was done by asking participant the following question in local language: How would you judge the degree of your glabellar lines by comparison to sample photos at this visit? The possible rating responses were: 0 = no visible vertical line(s) at all, 1 = slightly visible vertical line(s), 2 = moderate vertical line(s) with depression, and 3 = deep vertical line(s) and depression which cannot be effaced by spreading. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score. |
| Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at maximum frown on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at maximum frown on the 6-point Likert type scale was done by asking participant the following question in local language: How would you judge the potency of frown muscle action at this visit? The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher score reflecting higher potency. |
| Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at rest on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at rest on the 6-point Likert type scale was done by asking participant the following question in local language: How would you judge the degree of your glabellar lines at this visit? The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher scores reflecting higher degree of glabellar lines. |
| Time to Onset of Treatment Effect | From injection visit up to date of onset of treatment effect in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days) | Onset of treatment effect was analyzed using number of participants with corresponding onset of treatment effect, stratified by cycles. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
Participants with moderate to severe glabellar frown lines at maximum frown who completed one of the four feeder studies MRZ 60201-0520/1 (NCT00430963), MRZ 60201-0527/1 (NCT00430586), MRZ 60201-0724/1 (NCT00512135), or MRZ 60201-0741/1(NCT00512135) were enrolled in this repeat-dose study at 26 investigational sites in the United States, Canada and Germany.
Pre-assignment details
A total of 810 participants were screened, out of which 801 were enrolled into the study. Of these 801 participants, 796 received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| IncobotulinumtoxinA 20 U Participants, pre-treated with placebo, and incobotulinumtoxinA (NT 201) 10, 20 and 30 U in feeder studies; received incobotulinumtoxinA 20 U powder for solution for injection, intramuscularly, in equal aliquots to 5 injection sites (Point A \[one injection in procerus muscle at crossing of two lines that connect Point B and contralateral caruncle\], Point B \[one injection on each side in central part of corrugator muscle approximately 1 cm) above bony orbital rim on an imaginary line drawn vertically from caruncle\], and Point C \[one injection on each side in middle part of corrugator muscle at least 1.5 cm above bony orbital rim on an imaginary line drawn vertically from midpupillary line\]) on Day 0 of Cycle 1. Re-injections based on investigator assessment were performed on Day 0 of subsequent cycles (up to 8 cycles for participants enrolled from MRZ 60201-0520/1 and MRZ 60201-0527/1; and up to 2 cycles for participants enrolled from MRZ 60201-0724/1 and MRZ 60201-0741/1). Each cycle length \>=85 days. | 796 |
| Total | 796 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 27 |
| Overall Study | Not Treated | 5 |
| Overall Study | Other | 22 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | IncobotulinumtoxinA 20 U |
|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 26 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 81 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 8 Participants |
| Race/Ethnicity, Customized White | 669 Participants |
| Region of Enrollment Europe | 177 Participants |
| Region of Enrollment North America | 619 Participants |
| Sex: Female, Male Female | 702 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 796 |
| other Total, other adverse events | 169 / 796 |
| serious Total, serious adverse events | 29 / 796 |
Outcome results
Primary
Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown
Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at maximum frown on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at maximum frown on the 6-point Likert type scale was done by asking participant the following question in local language: How would you judge the potency of frown muscle action at this visit? The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher score reflecting higher potency.
Time frame: At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here overall participants analyzed are participants who were available for this outcome measure assessment and number analyzed n were the participants who were evaluable for this outcome measure at given time categories.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Evaluation Visit | Grade 0 | 118 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Evaluation Visit | Grade 1 | 256 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Evaluation Visit | Grade 2 | 210 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Evaluation Visit | Grade 3 | 140 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Evaluation Visit | Grade 4 | 46 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Evaluation Visit | Grade 5 | 16 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Evaluation Visit | Grade 0 | 99 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Evaluation Visit | Grade 1 | 228 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Evaluation Visit | Grade 2 | 187 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Evaluation Visit | Grade 3 | 114 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Evaluation Visit | Grade 4 | 39 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Evaluation Visit | Grade 5 | 23 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Evaluation Visit | Grade 0 | 52 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Evaluation Visit | Grade 1 | 113 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Evaluation Visit | Grade 2 | 84 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Evaluation Visit | Grade 3 | 44 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Evaluation Visit | Grade 4 | 19 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Evaluation Visit | Grade 5 | 7 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Evaluation Visit | Grade 0 | 57 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Evaluation Visit | Grade 1 | 96 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Evaluation Visit | Grade 2 | 83 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Evaluation Visit | Grade 3 | 49 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Evaluation Visit | Grade 4 | 16 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Evaluation Visit | Grade 5 | 4 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Evaluation Visit | Grade 0 | 51 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Evaluation Visit | Grade 1 | 98 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Evaluation Visit | Grade 2 | 84 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Evaluation Visit | Grade 3 | 35 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Evaluation Visit | Grade 4 | 19 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Evaluation Visit | Grade 5 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Evaluation Visit | Grade 0 | 44 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Evaluation Visit | Grade 1 | 95 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Evaluation Visit | Grade 2 | 64 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Evaluation Visit | Grade 3 | 39 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Evaluation Visit | Grade 4 | 14 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Evaluation Visit | Grade 5 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Evaluation Visit | Grade 0 | 25 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Evaluation Visit | Grade 1 | 74 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Evaluation Visit | Grade 2 | 49 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Evaluation Visit | Grade 3 | 32 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Evaluation Visit | Grade 4 | 9 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Evaluation Visit | Grade 5 | 1 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Evaluation Visit | Grade 0 | 5 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Evaluation Visit | Grade 1 | 22 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Evaluation Visit | Grade 2 | 14 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Evaluation Visit | Grade 3 | 5 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Evaluation Visit | Grade 4 | 1 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Evaluation Visit | Grade 5 | 1 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Last Control Visit | Grade 0 | 6 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Last Control Visit | Grade 1 | 28 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Last Control Visit | Grade 2 | 99 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Last Control Visit | Grade 3 | 223 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Last Control Visit | Grade 4 | 259 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 1: Last Control Visit | Grade 5 | 162 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Last Control Visit | Grade 0 | 9 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Last Control Visit | Grade 1 | 54 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Last Control Visit | Grade 2 | 97 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Last Control Visit | Grade 3 | 208 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Last Control Visit | Grade 4 | 208 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 2: Last Control Visit | Grade 5 | 105 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Last Control Visit | Grade 0 | 0 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Last Control Visit | Grade 1 | 10 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Last Control Visit | Grade 2 | 49 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Last Control Visit | Grade 3 | 100 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Last Control Visit | Grade 4 | 114 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 3: Last Control Visit | Grade 5 | 44 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Last Control Visit | Grade 0 | 0 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Last Control Visit | Grade 1 | 14 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Last Control Visit | Grade 2 | 41 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Last Control Visit | Grade 3 | 104 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Last Control Visit | Grade 4 | 90 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 4: Last Control Visit | Grade 5 | 55 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Last Control Visit | Grade 0 | 1 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Last Control Visit | Grade 1 | 16 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Last Control Visit | Grade 2 | 55 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Last Control Visit | Grade 3 | 89 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Last Control Visit | Grade 4 | 81 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 5: Last Control Visit | Grade 5 | 45 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Last Control Visit | Grade 0 | 2 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Last Control Visit | Grade 1 | 16 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Last Control Visit | Grade 2 | 52 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Last Control Visit | Grade 3 | 73 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Last Control Visit | Grade 4 | 83 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 6: Last Control Visit | Grade 5 | 31 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Last Control Visit | Grade 0 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Last Control Visit | Grade 1 | 16 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Last Control Visit | Grade 2 | 50 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Last Control Visit | Grade 3 | 51 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Last Control Visit | Grade 4 | 52 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 7: Last Control Visit | Grade 5 | 17 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Last Control Visit | Grade 0 | 0 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Last Control Visit | Grade 1 | 4 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Last Control Visit | Grade 2 | 14 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Last Control Visit | Grade 3 | 13 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Last Control Visit | Grade 4 | 13 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown | Cycle 8: Last Control Visit | Grade 5 | 4 Participants |
Primary
Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest
Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at rest on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at rest on the 6-point Likert type scale was done by asking participant the following question in local language: How would you judge the degree of your glabellar lines at this visit? The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher scores reflecting higher degree of glabellar lines.
Time frame: At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here overall participants analyzed are participants who were available for this outcome measure assessment and number analyzed n were the participants who were evaluable for this outcome measure at given time categories.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Evaluation Visit | Grade 0 | 237 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Evaluation Visit | Grade 1 | 281 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Evaluation Visit | Grade 2 | 144 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Evaluation Visit | Grade 3 | 89 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Evaluation Visit | Grade 4 | 28 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Evaluation Visit | Grade 5 | 7 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Evaluation Visit | Grade 0 | 205 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Evaluation Visit | Grade 1 | 251 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Evaluation Visit | Grade 2 | 150 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Evaluation Visit | Grade 3 | 57 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Evaluation Visit | Grade 4 | 15 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Evaluation Visit | Grade 5 | 12 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Evaluation Visit | Grade 0 | 98 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Evaluation Visit | Grade 1 | 111 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Evaluation Visit | Grade 2 | 72 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Evaluation Visit | Grade 3 | 29 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Evaluation Visit | Grade 4 | 5 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Evaluation Visit | Grade 5 | 4 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Evaluation Visit | Grade 0 | 90 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Evaluation Visit | Grade 1 | 123 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Evaluation Visit | Grade 2 | 53 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Evaluation Visit | Grade 3 | 34 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Evaluation Visit | Grade 4 | 2 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Evaluation Visit | Grade 5 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Evaluation Visit | Grade 0 | 92 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Evaluation Visit | Grade 1 | 111 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Evaluation Visit | Grade 2 | 52 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Evaluation Visit | Grade 3 | 25 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Evaluation Visit | Grade 4 | 7 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Evaluation Visit | Grade 5 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Evaluation Visit | Grade 0 | 80 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Evaluation Visit | Grade 1 | 102 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Evaluation Visit | Grade 2 | 55 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Evaluation Visit | Grade 3 | 13 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Evaluation Visit | Grade 4 | 6 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Evaluation Visit | Grade 5 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Evaluation Visit | Grade 0 | 59 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Evaluation Visit | Grade 1 | 76 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Evaluation Visit | Grade 2 | 37 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Evaluation Visit | Grade 3 | 12 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Evaluation Visit | Grade 4 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Evaluation Visit | Grade 5 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Evaluation Visit | Grade 0 | 12 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Evaluation Visit | Grade 1 | 27 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Evaluation Visit | Grade 2 | 6 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Evaluation Visit | Grade 3 | 2 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Evaluation Visit | Grade 4 | 1 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Evaluation Visit | Grade 5 | 0 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Last Control Visit | Grade 0 | 70 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Last Control Visit | Grade 1 | 204 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Last Control Visit | Grade 2 | 241 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Last Control Visit | Grade 3 | 163 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Last Control Visit | Grade 4 | 71 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 1: Last Control Visit | Grade 5 | 28 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Last Control Visit | Grade 0 | 98 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Last Control Visit | Grade 1 | 199 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Last Control Visit | Grade 2 | 190 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Last Control Visit | Grade 3 | 125 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Last Control Visit | Grade 4 | 50 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 2: Last Control Visit | Grade 5 | 19 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Last Control Visit | Grade 0 | 31 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Last Control Visit | Grade 1 | 81 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Last Control Visit | Grade 2 | 88 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Last Control Visit | Grade 3 | 81 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Last Control Visit | Grade 4 | 24 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 3: Last Control Visit | Grade 5 | 12 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Last Control Visit | Grade 0 | 32 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Last Control Visit | Grade 1 | 88 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Last Control Visit | Grade 2 | 82 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Last Control Visit | Grade 3 | 65 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Last Control Visit | Grade 4 | 30 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 4: Last Control Visit | Grade 5 | 7 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Last Control Visit | Grade 0 | 33 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Last Control Visit | Grade 1 | 71 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Last Control Visit | Grade 2 | 96 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Last Control Visit | Grade 3 | 55 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Last Control Visit | Grade 4 | 25 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 5: Last Control Visit | Grade 5 | 7 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Last Control Visit | Grade 0 | 34 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Last Control Visit | Grade 1 | 73 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Last Control Visit | Grade 2 | 90 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Last Control Visit | Grade 3 | 35 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Last Control Visit | Grade 4 | 20 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 6: Last Control Visit | Grade 5 | 5 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Last Control Visit | Grade 0 | 33 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Last Control Visit | Grade 1 | 64 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Last Control Visit | Grade 2 | 54 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Last Control Visit | Grade 3 | 24 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Last Control Visit | Grade 4 | 10 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 7: Last Control Visit | Grade 5 | 4 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Last Control Visit | Grade 0 | 3 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Last Control Visit | Grade 1 | 24 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Last Control Visit | Grade 2 | 10 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Last Control Visit | Grade 3 | 5 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Last Control Visit | Grade 4 | 6 Participants |
| IncobotulinumtoxinA 20 U | Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest | Cycle 8: Last Control Visit | Grade 5 | 0 Participants |
Primary
Incidence of Adverse Events (AEs)
Time frame: Baseline up to Month 30
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IncobotulinumtoxinA 20 U | Incidence of Adverse Events (AEs) | 374 Participants |
Primary
Incidence of Adverse Events of Special Interest (AESI)
Time frame: Baseline up to Month 30
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IncobotulinumtoxinA 20 U | Incidence of Adverse Events of Special Interest (AESI) | 9 Participants |
Primary
Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS)
FWS was used to assess the severity of glabellar frown lines at maximum frown by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1).
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here number analyzed n were the participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 1: Evaluation Visit | 79.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 2: Evaluation Visit | 79.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 3: Evaluation Visit | 80.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 4: Evaluation Visit | 80.3 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 5: Evaluation Visit | 81.4 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 6: Evaluation Visit | 81.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 7: Evaluation Visit | 82.7 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 8: Evaluation Visit | 89.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 1: Last Control Visit | 6.5 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 2: Last Control Visit | 16.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 3: Last Control Visit | 0.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 4: Last Control Visit | 0.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 5: Last Control Visit | 4.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 6: Last Control Visit | 8.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 7: Last Control Visit | 17.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS) | Cycle 8: Last Control Visit | 29.2 percentage of participants |
Primary
Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale
Participant's assessment of the glabellar frown lines at maximum frown on the 4-point scale was done by asking participant the following question in local language: How would you judge the potency of frown muscle action by comparison to sample photos at this visit? The possible rating responses were: 0 = no muscle action at all, 1 = some even slight muscle action possible, 2 = moderately strong muscle action possible, 3 = strong muscle action possible which may cause local pallor. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score.
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here number analyzed n were the participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 1: Evaluation Visit | 86.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 2: Evaluation Visit | 87.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 3: Evaluation Visit | 88.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 4: Evaluation Visit | 87.4 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 5: Evaluation Visit | 85.9 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 6: Evaluation Visit | 88.5 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 7: Evaluation Visit | 90.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 8: Evaluation Visit | 93.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 1: Last Control Visit | 31.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 2: Last Control Visit | 43.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 3: Last Control Visit | 38.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 4: Last Control Visit | 37.9 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 5: Last Control Visit | 43.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 6: Last Control Visit | 41.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 7: Last Control Visit | 52.4 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale | Cycle 8: Last Control Visit | 60.4 percentage of participants |
Primary
Percentage of Responders at Rest as Assessed by the Investigator According to FWS
FWS was used to assess the severity of glabellar frown lines at rest by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1). Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1).
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here number analyzed n were the participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 1: Evaluation Visit | 78.9 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 2: Evaluation Visit | 79.7 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 3: Evaluation Visit | 80.7 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 4: Evaluation Visit | 80.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 5: Evaluation Visit | 79.4 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 6: Evaluation Visit | 77.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 7: Evaluation Visit | 81.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 8: Evaluation Visit | 87.5 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 1: Last Control Visit | 57.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 2: Last Control Visit | 63.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 3: Last Control Visit | 63.7 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 4: Last Control Visit | 60.5 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 5: Last Control Visit | 63.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 6: Last Control Visit | 64.4 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 7: Last Control Visit | 67.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest as Assessed by the Investigator According to FWS | Cycle 8: Last Control Visit | 83.3 percentage of participants |
Primary
Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale
Participant's assessment of the glabellar frown lines at rest on the 4-point scale was done by asking participant the following question in local language: How would you judge the degree of your glabellar lines by comparison to sample photos at this visit? The possible rating responses were: 0 = no visible vertical line(s) at all, 1 = slightly visible vertical line(s), 2 = moderate vertical line(s) with depression, and 3 = deep vertical line(s) and depression which cannot be effaced by spreading. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score.
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here number analyzed n were the participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 1: Evaluation Visit | 69.5 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 2: Evaluation Visit | 67.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 3: Evaluation Visit | 73.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 4: Evaluation Visit | 73.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 5: Evaluation Visit | 77.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 6: Evaluation Visit | 75.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 7: Evaluation Visit | 75.9 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 8: Evaluation Visit | 77.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 1: Last Control Visit | 35.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 2: Last Control Visit | 43.2 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 3: Last Control Visit | 38.8 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 4: Last Control Visit | 42.1 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 5: Last Control Visit | 43.6 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 6: Last Control Visit | 49.0 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 7: Last Control Visit | 54.5 percentage of participants |
| IncobotulinumtoxinA 20 U | Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale | Cycle 8: Last Control Visit | 58.3 percentage of participants |
Primary
Time to Onset of Treatment Effect
Onset of treatment effect was analyzed using number of participants with corresponding onset of treatment effect, stratified by cycles.
Time frame: From injection visit up to date of onset of treatment effect in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Population: The FAS consists of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n were the participants who were evaluable for this outcome measure at given time points.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 0 | 1 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 1 | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 2 | 4 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | None | 15 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 0 | 10 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 1 | 86 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 2 | 168 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 3 | 171 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 4 | 93 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 5 | 75 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 6 | 33 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 7 | 70 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 8 | 12 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day 9 | 5 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 1 | Day >=10 | 48 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | None | 20 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 0 | 22 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 1 | 106 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 2 | 134 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 3 | 138 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 4 | 82 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 5 | 53 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 6 | 17 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 7 | 58 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 8 | 10 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day 9 | 9 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 2 | Day >=10 | 41 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | None | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 0 | 8 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 1 | 44 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 2 | 56 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 3 | 70 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 4 | 46 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 5 | 36 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 6 | 11 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 7 | 18 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 8 | 3 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day 9 | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 3 | Day >=10 | 15 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | None | 4 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 0 | 10 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 1 | 39 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 2 | 54 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 3 | 78 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 4 | 33 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 5 | 29 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 6 | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 7 | 22 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 8 | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day 9 | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 4 | Day >=10 | 18 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | None | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 0 | 9 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 1 | 37 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 2 | 64 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 3 | 57 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 4 | 39 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 5 | 21 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 6 | 17 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 7 | 20 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 8 | 5 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day 9 | 4 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 5 | Day >=10 | 11 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | None | 2 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 0 | 10 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 1 | 33 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 2 | 46 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 3 | 56 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 4 | 42 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 5 | 20 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 6 | 5 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 7 | 21 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 8 | 7 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day 9 | 2 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 6 | Day >=10 | 15 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | None | 3 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 0 | 8 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 1 | 17 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 2 | 36 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 3 | 43 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 4 | 29 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 5 | 19 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 6 | 8 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 7 | 15 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 8 | 6 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day 9 | 1 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 7 | Day >=10 | 5 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | None | 0 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 3 | 17 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 4 | 4 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 5 | 7 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 6 | 2 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 7 | 4 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 8 | 2 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day 9 | 0 Participants |
| IncobotulinumtoxinA 20 U | Time to Onset of Treatment Effect | Cycle 8 | Day >=10 | 1 Participants |