HyperhidrosisNCT02043145

Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea

An observational study of Hyperhidrosis and Muscle Spasticity, run by Allergan at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hyperhidrosis, Muscle Spasticity, Glabellar Lines
What is being tested?: botulinum toxin Type A
How many people: 727 participants
Where: 1 siteSouth Korea
Study dates: Jul 2008to Apr 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
No healthy volunteers
Adult, Older adult

Study population: Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

Who may be able to join

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.

Who cannot join

None.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Seoul

Other trials in South Korea

About this study

Conditions: Hyperhidrosis, Muscle Spasticity, Glabellar Lines
Being tested: botulinum toxin Type A
Medical subject headings: Hyperhidrosis, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

botulinum toxin Type ABiological
Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

Study groups in NCT02043145
Study group	Role	What they receive
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. Receives: Biological: botulinum toxin Type A
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. Receives: Biological: botulinum toxin Type A
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. Receives: Biological: botulinum toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 Years
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.
Measured: Pre-dose (Baseline), Post-dose (Up to 4 Years)
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.
Measured: Pre-dose (Baseline), Post-dose (Up to 4 Years)
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.
Measured: Pre-dose (Baseline), Post-dose (Up to 4 Years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Apr 2012

First posted23 Jan 2014 (estimated)
Study startJul 2008
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperhidrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 727 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02043145
Sponsor's protocol ID: EPI-MULT-100
Status last verified: May 2014
First submitted: 21 Jan 2014
Last updated: 13 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
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All Hyperhidrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea
ClinicalTrials.gov ID: NCT02043145
Acronym / sponsor ID: EPI-MULT-100
Conditions: Hyperhidrosis, Muscle Spasticity, Glabellar Lines
Study type: Observational
Recruitment status: Completed
Enrolment: 727 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Axillary Hyperhidrosis	–	Biological: botulinum toxin Type APatients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
Focal Spasticity	–	Biological: botulinum toxin Type APatients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
Glabellar Lines	–	Biological: botulinum toxin Type APatients 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.

Who may qualify

Ages: 18 to 65 years
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

None.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
botulinum toxin Type ABotulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.	Biological	Axillary Hyperhidrosis, Focal Spasticity, Glabellar Lines

Primary outcome

Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 13 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Axillary Hyperhidrosis	55	55
Focal Spasticity	247	247
Glabellar Lines	425	425

Primary outcome: Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)

Time frame: 4 Years. Number. Unit: participants

Measure	Axillary Hyperhidrosis n = 55	Focal Spasticity n = 237	Glabellar Lines n = 423
Adverse Events	0	6	5
Serious Adverse Drug Reactions	0	0	0

Population analysed: Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.

Primary outcome: Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale

Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years). Mean (Standard Deviation). Unit: score on a scale

Measure	Axillary Hyperhidrosis n = 54
Pre-dose (Baseline)	2.93 (0.72)
Change from Baseline at Post-dose	-1.61 (0.79)

Population analysed: 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.

Primary outcome: Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale

Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years). Mean (Standard Deviation). Unit: score on a scale

Measure	Focal Spasticity n = 167
Pre-dose (Baseline)	2.85 (0.73)
Change from Baseline at Post-dose	-1.22 (0.64)

Primary outcome: Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale

Time frame: Pre-dose (Baseline), Post-dose (Up to 4 Years). Mean (Standard Deviation). Unit: score on a scale

Measure	Glabellar Lines n = 383
Pre-dose (Baseline)	2.27 (0.56)
Change from Baseline at Post-dose	-1.53 (0.54)

Adverse events

Time frame: Adverse Events were collected for Up to 4 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Axillary Hyperhidrosis	0 of 55 (0%)	0 of 55 (0%)	Not reported
Focal Spasticity	0 of 237 (0%)	0 of 237 (0%)	Not reported
Glabellar Lines	0 of 423 (0%)	0 of 423 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperhidrosis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperhidrosis and Muscle Spasticity, run by Allergan at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) (time frame: 4 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.