| Primary | Incidence of Adverse Events (AEs) | | 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. | Posted | | Count of Participants | | Participants | | Baseline up to Month 30 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | Incidence of Adverse Events of Special Interest (AESI) | | 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. | Posted | | Count of Participants | | Participants | | Baseline up to Month 30 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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). | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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). | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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