Glabellar Lines, Hyperhidrosis, Muscle Spasticity
Conditions
Brief summary
This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.
Interventions
BIOLOGICALbotulinum toxin Type A
Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | 4 Years | An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event. |
| Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale | Pre-dose (Baseline), Post-dose (Up to 4 Years) | Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement. |
| Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale | Pre-dose (Baseline), Post-dose (Up to 4 Years) | The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement. |
| Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale | Pre-dose (Baseline), Post-dose (Up to 4 Years) | The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Axillary Hyperhidrosis Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. | 55 |
| Focal Spasticity Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. | 237 |
| Glabellar Lines Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. | 423 |
| Total | 715 |
Baseline characteristics
| Characteristic | Axillary Hyperhidrosis | Focal Spasticity | Glabellar Lines | Total |
|---|---|---|---|---|
| Age, Customized 30 to 39 years | 21 Participants | 21 Participants | 154 Participants | 196 Participants |
| Age, Customized < 30 years | 24 Participants | 30 Participants | 67 Participants | 121 Participants |
| Age, Customized 40 to 49 years | 6 Participants | 56 Participants | 112 Participants | 174 Participants |
| Age, Customized >=50 years | 4 Participants | 130 Participants | 90 Participants | 224 Participants |
| Sex: Female, Male Female | 48 Participants | 78 Participants | 376 Participants | 502 Participants |
| Sex: Female, Male Male | 7 Participants | 159 Participants | 47 Participants | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 237 | 0 / 423 |
| serious Total, serious adverse events | 0 / 55 | 0 / 237 | 0 / 423 |
Outcome results
Primary
Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale
Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement.
Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years)
Population: Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axillary Hyperhidrosis | Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale | Pre-dose (Baseline) | 2.93 score on a scale | Standard Deviation 0.72 |
| Axillary Hyperhidrosis | Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale | Change from Baseline at Post-dose | -1.61 score on a scale | Standard Deviation 0.79 |
Primary
Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale
The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement.
Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years)
Population: Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axillary Hyperhidrosis | Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale | Pre-dose (Baseline) | 2.27 score on a scale | Standard Deviation 0.56 |
| Axillary Hyperhidrosis | Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale | Change from Baseline at Post-dose | -1.53 score on a scale | Standard Deviation 0.54 |
Primary
Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale
The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement.
Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years)
Population: Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axillary Hyperhidrosis | Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale | Pre-dose (Baseline) | 2.85 score on a scale | Standard Deviation 0.73 |
| Axillary Hyperhidrosis | Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale | Change from Baseline at Post-dose | -1.22 score on a scale | Standard Deviation 0.64 |
Primary
Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)
An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event.
Time frame: 4 Years
Population: Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axillary Hyperhidrosis | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Events | 0 participants |
| Axillary Hyperhidrosis | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | Serious Adverse Drug Reactions | 0 participants |
| Focal Spasticity | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Events | 6 participants |
| Focal Spasticity | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | Serious Adverse Drug Reactions | 0 participants |
| Glabellar Lines | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Events | 5 participants |
| Glabellar Lines | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | Serious Adverse Drug Reactions | 0 participants |