Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

NCT ID: NCT03647982

Last Updated: 2019-03-26

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

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-11-20

Brief Summary

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To determine the anhidrotic area and safety of MEDITOXIN

Detailed Description

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Conditions

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Anhidrotic Area Hyperhidrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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botulinum toxin 1U

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Botox

Intervention Type DRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

botulinum toxin 3U(25U/1ml)

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Botox

Intervention Type DRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

botulinum toxin 5U

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Botox

Intervention Type DRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

botulinum toxin 10U

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Botox

Intervention Type DRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

botulinum toxin 3U(50U/1ml)

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Botox

Intervention Type DRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

botulinum toxin 3U(12.5U/1ml)

Group Type EXPERIMENTAL

Meditoxin

Intervention Type DRUG

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Botox

Intervention Type DRUG

injection of Botox into the intradermal of each contralateral upper back in equal doses

Interventions

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Meditoxin

injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

Intervention Type DRUG

Botox

injection of Botox into the intradermal of each contralateral upper back in equal doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

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-KR17PAH110

Identifier Type: -

Identifier Source: org_study_id

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