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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Drug: Botulinum Toxin Type A(Meditoxin®); Drug: Botulinum Toxin Type A(Botox®)

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.

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Seoul ASAN Medical Center
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Medical Center
  • Seoul, Korea, Republic of, 120-749
    • Sevrance Medical Center
  • Seoul, Korea, Republic of, 130-709
    • St. Paul Hospital
  • Seoul, Korea, Republic of, 140-013
    • Chung-Ang University Yong-san Hospital
  • Gyoung-gi Do
    • Seongnam si, Gyoung-gi Do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin type A(Meditoxin®)	Drug: Botulinum Toxin Type A(Meditoxin®); single administration, Day 0, 20U; Other Names: Neuronox®, Siax®
Active Comparator: Botulinum toxin type A(Botox®)	Drug: Botulinum Toxin Type A(Botox®); single administration, Day 0, 20U

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity	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	0 and 4 weeks after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment	Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection	0, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity	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	0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment	Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection	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	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	0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate confirmed with subject's assessment	Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection	4, 8, 12 and 16 weeks after the injection
Subject satisfaction rate	Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection	4, 8, 12 and 16 weeks after the injection

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62.
• Kriegl L, Horst D, Kirchner T, Jung A. LEF-1 expression in basal cell carcinomas. Br J Dermatol. 2009 Jun;160(6):1353-6. doi: 10.1111/j.1365-2133.2009.09144.x. Epub 2009 Mar 30. No abstract available.
• Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
• Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2009
• Primary Completion (Actual): August 30, 2010
• Study Completion (Actual): September 30, 2010

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: CSP-MDTX-GL-0901