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Trial record 54 of 720 for:    Botulinum Toxins, Type A

Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines

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: NCT03289169
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief Summary:
This study evaluate the long-term safety of repeated administraions of meditoxin® in the treatment of moderate to severe glabellar lines.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: MEDITOXIN® Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line
Actual Study Start Date : December 30, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: MEDITOXIN
Meditoxin(Botulinum toxin type A)
Drug: MEDITOXIN®
20U of meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.
Other Name: Neuronox®




Primary Outcome Measures :
  1. Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment [ Time Frame: 4 weeks after final injection ]
    improvement are defined as subjects with glabellar line severity of none (0) or mild (1).


Secondary Outcome Measures :
  1. Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment [ Time Frame: 4 weeks after each injection ]
    Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection

  2. Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment [ Time Frame: 4 weeks after each injection ]
    Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection



Information from the National Library of Medicine

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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:

  • Men and women aged between 20 and 65
  • Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
  • Patients who can comply with the study procedures and visit schedule
  • Patients who voluntarily sign the informed consent

Exclusion Criteria:

  • Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
  • Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
  • Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
  • Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
  • Patients who were injected with botulinum toxin within the past 3 months
  • Patients with allergy or hypersensitivity to the investigational drugs or their components
  • Patients who have bleeding tendency or taking anti-coagulant
  • Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
  • Patients with skin disorders or infection at the injection site
  • Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
  • Patients who are unable to communicate or follow the instructions
  • Patients who are not eligible for this study based on the judgment of an investigator

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): NCT03289169


Contacts
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Contact: Rang Lee 82-2-6901-5869 rang531@medytox.com

Locations
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Korea, Republic of
St. Paul Hospital Recruiting
Seoul, Korea, Republic of, 130-709
Contact: Hoon Kang, M.D., Ph.D.    +82-2-958-2143    johnkang@catholic.ac.kr   
Sponsors and Collaborators
Medy-Tox

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03289169     History of Changes
Other Study ID Numbers: MT01-KR16GBL401
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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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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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