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Completed

NCT Number: NCT01237977

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

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.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyoung-gi Do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A(Meditoxin®)

Drug

single administration, Day 0, 20U

Other names: Neuronox®, Siax®

Botulinum toxin type A(Botox®)

Drug

single administration, Day 0, 20U

Primary outcomes

  1. Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity

    Time frame: 0 and 4 weeks after the injection

    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 outcomes

  1. Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment

    Time frame: 0, 8, 12 and 16 weeks after the injection

    Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection

  2. 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

    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

  3. 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

    Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection

  4. 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

    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

  5. Glabellar line improvement rate confirmed with subject's assessment

    Time frame: 4, 8, 12 and 16 weeks after the injection

    Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection

  6. Subject satisfaction rate

    Time frame: 4, 8, 12 and 16 weeks after the injection

    Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2010
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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