Trial | NCT01237977  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rimabotulinumtoxinB ...

  • Study Participants

    314
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.
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.
Study Started
Nov 23
2009
Primary Completion
Aug 30
2010
Study Completion
Sep 30
2010
Last Update
Mar 28
2019

Drug Botulinum Toxin Type A(Botox®)

single administration, Day 0, 20U

Drug Botulinum Toxin Type A(Meditoxin®)

single administration, Day 0, 20U

  • Other names: Neuronox®, Siax®

Botulinum toxin type A(Meditoxin®) Experimental

Botulinum toxin type A(Botox®) Active Comparator

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
No Results Posted