Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

Hyperhidrosis Clinical Trial

Official title:

Open-Label, Active Controlled, Single-Center, Phase 1 Study to Determine the Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647982
• Other study ID #: MT01-KR17PAH110
• Status: Completed
• Phase: Phase 1
• Start date: March 20, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the anhidrotic area and safety of MEDITOXIN

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 20, 2018
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anhidrotic Area
• Hyperhidrosis

Intervention

Drug:
• Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses
• Botox
injection of Botox into the intradermal of each contralateral upper back in equal doses

Locations

Country	Name	City	State
Korea, Republic of	Catholic University St. Paul Hospital	Seoul	Dongdaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anhidrotic area	After the ninhydrin sweat test, measure the area of the unstained area	week 4