N/A
Completed N=727
Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea
Hyperhidrosis · Muscle Spasticity · Glabellar Lines
Source: ClinicalTrials.gov NCT02043145 ↗
Enrolled (actual)
727
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) — 0; 6; 5; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) |
0; 6; 5; 0; 0; 0 | — |
| PRIMARY Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale |
2.93; -1.61 | — |
| PRIMARY Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale |
2.85; -1.22 | — |
| PRIMARY Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale |
2.27; -1.53 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02043145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.