Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis

Hyperhidrosis Primary Focal Axilla Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760198
• Other study ID #: MT01-KR17PAH311
• Status: Completed
• Phase: Phase 3
• Start date: August 3, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo in treatment of primary axillary hyperhidrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 17, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis
• Hyperhidrosis Primary Focal Axilla

Intervention

Drug:
• Meditoxin
50U of MEDITOXIN is injected intradermally to each axilla

Other:
• Placebo
normal saline is injected intradermally to each axilla

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	the proportion of treatment responder	subjects who reported at least a 2-point improvement from baseline HDSS score	4 weeks after the injection