Back to resultsEvaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
Primary Purpose
Hyperhidrosis Primary Focal Axilla
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meditoxin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis Primary Focal Axilla
Eligibility Criteria
Inclusion Criteria:
- adult patients aged from 20 to 65, with persistent bilateral primary axillary hyperhidrosis
Exclusion Criteria:
- those who have secondary hyperhidrosis
- those who have systemic neuromuscular junction disorders
- women who are pregnant or lactating
Sites / Locations
- Catholic University St. Paul Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
botulinum toxin type A
Placebo
Arm Description
Outcomes
Primary Outcome Measures
the proportion of treatment responder
subjects who reported at least a 2-point improvement from baseline HDSS score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03760198
Brief Title
Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
Official Title
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo in treatment of primary axillary hyperhidrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis Primary Focal Axilla
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin type A
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Meditoxin
Intervention Description
50U of MEDITOXIN is injected intradermally to each axilla
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
normal saline is injected intradermally to each axilla
Primary Outcome Measure Information:
Title
the proportion of treatment responder
Description
subjects who reported at least a 2-point improvement from baseline HDSS score
Time Frame
4 weeks after the injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients aged from 20 to 65, with persistent bilateral primary axillary hyperhidrosis
Exclusion Criteria:
those who have secondary hyperhidrosis
those who have systemic neuromuscular junction disorders
women who are pregnant or lactating
Facility Information:
Facility Name
Catholic University St. Paul Hospital
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
130-709
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
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