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Trial record 14 of 166 for:    "Sweat Gland Disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03760198
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Primary Focal Axilla Drug: Meditoxin Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: botulinum toxin type A Drug: Meditoxin
50U of MEDITOXIN is injected intradermally to each axilla

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760198


Locations
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Korea, Republic of
Catholic University St. Paul Hospital Recruiting
Seoul, Dongdaemun-gu, Korea, Republic of, 130-709
Contact: Hoon Kang    02-958-2143    johnkang@catholic.ac.kr   
Principal Investigator: Hoon Kang         
Sponsors and Collaborators
Medy-Tox

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03760198     History of Changes
Other Study ID Numbers: MT01-KR17PAH311
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents