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

NCT ID: NCT03760198

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2019-09-17

Brief Summary

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

Detailed Description

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Conditions

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Hyperhidrosis Primary Focal Axilla

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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botulinum toxin type A

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

50U of MEDITOXIN is injected intradermally to each axilla

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

normal saline is injected intradermally to each axilla

Interventions

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Meditoxin

50U of MEDITOXIN is injected intradermally to each axilla

Intervention Type DRUG

Placebo

normal saline is injected intradermally to each axilla

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Catholic University St. Paul Hospital

Seoul, Dongdaemun-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT01-KR17PAH311

Identifier Type: -

Identifier Source: org_study_id

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