Last updated: 05/29/2019 19:10:10

Special Drug Use Investigation of BOTOX for Axillary Hyperhidrosis

GSK study ID
116953
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2017-28-08
    Observational study model:
    Case-Only
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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
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