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OpenTrials
Completed

NCT Number: NCT03760198

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.

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Key information

Conditions

Hyperhidrosis Primary Focal Axilla

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catholic University St. Paul Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditoxin

Drug

50U of MEDITOXIN is injected intradermally to each axilla

Placebo

Other

normal saline is injected intradermally to each axilla

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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