Back to resultsAnhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers
Primary Purpose
Anhidrotic Area, Hyperhidrosis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meditoxin
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Anhidrotic Area
Eligibility Criteria
Inclusion Criteria:
- Male adults aged between 20 and 45 years
Exclusion Criteria:
- Subjects not appropriate for participating in this study according to the investigator's opinion
Sites / Locations
- Catholic University St. Paul Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
botulinum toxin 1U
botulinum toxin 3U(25U/1ml)
botulinum toxin 5U
botulinum toxin 10U
botulinum toxin 3U(50U/1ml)
botulinum toxin 3U(12.5U/1ml)
Arm Description
Outcomes
Primary Outcome Measures
anhidrotic area
After the ninhydrin sweat test, measure the area of the unstained area
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03647982
Brief Title
Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers
Official Title
Open-Label, Active Controlled, Single-Center, Phase 1 Study to Determine the Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (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
To determine the anhidrotic area and safety of MEDITOXIN
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhidrotic Area, Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin 1U
Arm Type
Experimental
Arm Title
botulinum toxin 3U(25U/1ml)
Arm Type
Experimental
Arm Title
botulinum toxin 5U
Arm Type
Experimental
Arm Title
botulinum toxin 10U
Arm Type
Experimental
Arm Title
botulinum toxin 3U(50U/1ml)
Arm Type
Experimental
Arm Title
botulinum toxin 3U(12.5U/1ml)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Meditoxin
Intervention Description
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
injection of Botox into the intradermal of each contralateral upper back in equal doses
Primary Outcome Measure Information:
Title
anhidrotic area
Description
After the ninhydrin sweat test, measure the area of the unstained area
Time Frame
week 4
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male adults aged between 20 and 45 years
Exclusion Criteria:
Subjects not appropriate for participating in this study according to the investigator's opinion
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
Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers
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