Last updated: 05/29/2019 19:10:10
Special Drug Use Investigation of BOTOX for Axillary Hyperhidrosis
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation of BOTOX for Axillary Hyperhidrosis
Trial description: This post-marketing surveillance (PMS) is conducted in Japan under clinical practice to collect safety and efficacy data in patients with severe primary axillary hyperhidrosis who are treated with botulinum toxin for the first time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse drug reactions
Timeframe: 1 year
Occurrence of adverse events of compensatory sweating
Timeframe: 1 year
Secondary outcomes:
Changes in Hyperhidrosis Disease Severity Scale (HDSS) scores
Timeframe: 1 year
Interventions:
Drug: Botulinum toxin A
Enrollment:
Not applicable
Observational study model:
Case-Only
Primary completion date:
2017-28-08
Time perspective:
Prospective
Clinical publications:
Yuna Onaka, Yoshiyuki Yamashita, Shinya Nachi, Takeshi Ebihara, Terufumi Hara, Pascal Yoshida. Safety and Effectiveness of Botulinum Toxin Type A (BOTOX®) in Patients with axillary hyperhidrosis: Results of Special Drug Use Investigation. Prog Med. 2019
Medical condition
Hyperhidrosis
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
March 2013 to August 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Patients with severe primary axillary hyperhidrosis
- Patients who are treated with botulinum toxin for the first time
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with severe primary axillary hyperhidrosis
- Patients who are treated with botulinum toxin for the first time
- Patients who are expected to be observed for 1 year
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2017-28-08
Actual study completion date
2017-28-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website