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Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

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ClinicalTrials.gov Identifier: NCT03647982
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief Summary:
To determine the anhidrotic area and safety of MEDITOXIN

Condition or disease Intervention/treatment Phase
Anhidrotic Area Hyperhidrosis Drug: Meditoxin Drug: Botox Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Open-Label, Active Controlled, Single-Center, Phase 1 Study to Determine the Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Volunteers
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : October 20, 2018
Estimated Study Completion Date : December 20, 2018

Arm Intervention/treatment
Experimental: botulinum toxin 1U Drug: Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

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

Experimental: botulinum toxin 3U(25U/1ml) Drug: Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

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

Experimental: botulinum toxin 5U Drug: Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

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

Experimental: botulinum toxin 10U Drug: Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

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

Experimental: botulinum toxin 3U(50U/1ml) Drug: Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

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

Experimental: botulinum toxin 3U(12.5U/1ml) Drug: Meditoxin
injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses

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




Primary Outcome Measures :
  1. anhidrotic area [ Time Frame: week 4 ]
    After the ninhydrin sweat test, measure the area of the unstained area



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03647982


Locations
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

Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03647982     History of Changes
Other Study ID Numbers: MT01-KR17PAH110
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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

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