NCT03647982

Brief Summary

To determine the anhidrotic area and safety of MEDITOXIN

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

August 23, 2018

Last Update Submit

March 25, 2019

Conditions

Anhidrotic AreaHyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • anhidrotic area

    After the ninhydrin sweat test, measure the area of the unstained area

    week 4

Study Arms (6)

botulinum toxin 1U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 3U(25U/1ml)

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 5U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 10U

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 3U(50U/1ml)

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

botulinum toxin 3U(12.5U/1ml)

EXPERIMENTAL
Drug: MeditoxinDrug: Botox

Interventions

MeditoxinDRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

botulinum toxin 10Ubotulinum toxin 1Ubotulinum toxin 3U(12.5U/1ml)botulinum toxin 3U(25U/1ml)botulinum toxin 3U(50U/1ml)botulinum toxin 5U
BotoxDRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

botulinum toxin 10Ubotulinum toxin 1Ubotulinum toxin 3U(12.5U/1ml)botulinum toxin 3U(25U/1ml)botulinum toxin 3U(50U/1ml)botulinum toxin 5U

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male adults aged between 20 and 45 years

You may not qualify if:

  • Subjects not appropriate for participating in this study according to the investigator's opinion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University St. Paul Hospital

Seoul, Dongdaemun-gu, 130-709, South Korea

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 27, 2018

Study Start

March 20, 2018

Primary Completion

October 20, 2018

Study Completion

November 20, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

KR(1)