Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines

This study has been completed.
Sponsor:
Information provided by:
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01237977
First received: November 4, 2010
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.


Condition Intervention Phase
Skin Aging
Drug: Botulinum Toxin Type A(Meditoxin®)
Drug: Botulinum Toxin Type A(Botox®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of "Meditoxin® Versus Botox® in the Treatment of Glabellar Lines

Resource links provided by NLM:


Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity [ Time Frame: 0 and 4 weeks after the injection ] [ Designated as safety issue: No ]
    Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection


Secondary Outcome Measures:
  • Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment [ Time Frame: 0, 8, 12 and 16 weeks after the injection ] [ Designated as safety issue: No ]
    Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection

  • Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity [ Time Frame: 0, 4, 8, 12 and 16 weeks after the injection ] [ Designated as safety issue: No ]
    Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection

  • Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment [ Time Frame: 0, 4, 8,12 and 16 weeks after the injection ] [ Designated as safety issue: No ]
    Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection

  • Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity [ Time Frame: 0, 4, 8, 12 and 16 weeks after the injection ] [ Designated as safety issue: No ]
    Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection

  • Glabellar line improvement rate confirmed with subject's assessment [ Time Frame: 4, 8, 12 and 16 weeks after the injection ] [ Designated as safety issue: No ]
    Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection

  • Subject satisfaction rate [ Time Frame: 4, 8, 12 and 16 weeks after the injection ] [ Designated as safety issue: No ]
    Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection


Enrollment: 314
Study Start Date: November 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin type A(Meditoxin®) Drug: Botulinum Toxin Type A(Meditoxin®)
single administration, Day 0, 20U
Other Name: Neuronox®, Siax®
Active Comparator: Botulinum toxin type A(Botox®) Drug: Botulinum Toxin Type A(Botox®)
single administration, Day 0, 20U

Detailed Description:

The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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 severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.)
  • Patients who have bleeding tendency or taking anti-coagulant
  • Patients who were injected with botulinum toxin within the past 3 months
  • Patients with allergy or hypersensitivity to the investigational drugs or their components
  • 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 the history of facial nerve paralysis or the symptoms of eyelid ptosis
  • Patients with skin disorders or infection at the injection site
  • Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
  • Patients with the history of treatment of glabellar part(including forehead) like face lifting and permanent implant or with scars which may affect the treatment results
  • Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
  • Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
  • Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening or the five times the half life of a drug which was given to patient during the previous clinical trials
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237977

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam si, Gyoung-gi do, Korea, Republic of, 463-707
Chung-Ang University Yong-San Hospital
Seoul, Korea, Republic of, 140-013
Kangbuk Samsung Medical Center
Seoul, Korea, Republic of, 110-746
Seoul Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sevrance Medical Center
Seoul, Korea, Republic of, 120-749
St. Paul Hospital
Seoul, Korea, Republic of, 130-709
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: Chang-Hun Huh, MD, Ph.D. Seoul National University Bundang Hospital
Principal Investigator: Hoon Kang, MD, Ph.D. St. Paul Hospital
Principal Investigator: Won-Seok Kim, MD, Ph.D. Kang-Buk Samsung Medical Center
Principal Investigator: Jong-Hyun Won, MD, Ph.D. Seoul Asan Medical Center
Principal Investigator: Joo-Hee Lee, MD, Ph.D. Sevrance Medical Center
Principal Investigator: Beom-Joon Kim, MD, Ph.D. Chung-Ang University Yong-San Hospital
  More Information

Publications:
Responsible Party: Yujin Sun / Assistant manager, Medy-Tox Inc.
ClinicalTrials.gov Identifier: NCT01237977     History of Changes
Other Study ID Numbers: CSP-MDTX-GL-0901
Study First Received: November 4, 2010
Last Updated: April 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014