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

July 27, 2020 updated by: Medy-Tox

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongdaemun-gu
      • Seoul, Dongdaemun-gu, Korea, Republic of, 130-709
        • Catholic University St. Paul Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo
normal saline is injected intradermally to each axilla
EXPERIMENTAL: botulinum toxin type A
Drug: Meditoxin
50U of MEDITOXIN is injected intradermally to each axilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of treatment responder
Time Frame: 4 weeks after the injection
subjects who reported at least a 2-point improvement from baseline HDSS score
4 weeks after the injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2018

Primary Completion (ACTUAL)

July 3, 2019

Study Completion (ACTUAL)

September 17, 2019

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (ACTUAL)

November 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT01-KR17PAH311

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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