NCT03647982CompletedPhase 1
Open-Label, Active Controlled, Single-Center, Phase 1 Study to Determine the Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Volunteers
Medy-Tox1 site in 1 country13 target enrollmentStarted: March 20, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- anhidrotic area
Study Overview
Brief Summary
To determine the anhidrotic area and safety of MEDITOXIN
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
botulinum toxin 1U
Experimental
Intervention: Meditoxin (Drug)
botulinum toxin 1U
Experimental
Intervention: Botox (Drug)
botulinum toxin 3U(25U/1ml)
Experimental
Intervention: Meditoxin (Drug)
botulinum toxin 3U(25U/1ml)
Experimental
Intervention: Botox (Drug)
botulinum toxin 5U
Experimental
Intervention: Meditoxin (Drug)
botulinum toxin 5U
Experimental
Intervention: Botox (Drug)
botulinum toxin 10U
Experimental
Intervention: Meditoxin (Drug)
botulinum toxin 10U
Experimental
Intervention: Botox (Drug)
botulinum toxin 3U(50U/1ml)
Experimental
Intervention: Meditoxin (Drug)
botulinum toxin 3U(50U/1ml)
Experimental
Intervention: Botox (Drug)
botulinum toxin 3U(12.5U/1ml)
Experimental
Intervention: Meditoxin (Drug)
botulinum toxin 3U(12.5U/1ml)
Experimental
Intervention: Botox (Drug)
Outcomes
Primary Outcomes
anhidrotic area
Time Frame: week 4
After the ninhydrin sweat test, measure the area of the unstained area
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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