To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines

Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines

To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Drug: Botulinum toxin type A(Botulax®); Drug: Botulinum toxin type A(Botox®)

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of
      • Chung-Ang University Hopspital
  • Jongno-Gu
    • Seoul, Jongno-Gu, Korea, Republic of
      • Seoul National University Hospital
  • Jung-Gu
    • Seoul, Jung-Gu, Korea, Republic of
      • National Medical Center
  • Nowon-Gu
    • Seoul, Nowon-Gu, Korea, Republic of
      • Eulji General Hospital
  • Seocho-Gu
    • Seoul, Seocho-Gu, Korea, Republic of
      • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seongbuk-Gu
    • Seoul, Seongbuk-Gu, Korea, Republic of
      • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged between 18 and 65
• Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
• Patients who voluntarily sign the informed consent
• Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

• Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
• Subjects with skin disorders, scar or infection around glabellar region
• Subjects who are taking Aspirin, NSAIDS or anti-coagulant
• Subjects with facial palsy or eyelid ptosis
• Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
• Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder
• Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)
• Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)
• Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants
• Subjects who have possibility to take the drugs listed above
• Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period
• Subjects who have glabellar lines that are unable to be improved with any physical method
• Subjects who have history of hypersensitivity to Botulinum toxin and other agents
• Subjects who are pregnant or breast-feeding
• Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive
• Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product
• Subjects who are having trouble with acute disease
• Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months
• Subjects who are unable to communicate or follow the instructions
• Subjects who are not eligible for this study based on investigator's judgement

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum toxin type A(Botox®); Botulinum toxin type A	Drug: Botulinum toxin type A(Botulax®); Single administration, Day 0, 20 units
Experimental: Botulinum toxin type A (Botulax®); Botulinum toxin type A	Drug: Botulinum toxin type A(Botox®); Single administration, Day 0, 20units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate of improvement in glabellar lines with Physician's rating of line severity	Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.	at 4 weeks post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation in experimental drug treatment group		4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines with Physician's rating of line severity	Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.	8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity	Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment	Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment	Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post inejection
Responder rate of improvement in glabellar lines with Subject's improvement assessment	Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post-injections
Subject's satisfaction rate	Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection	4, 8, 12, 16 weeks post-injection

Collaborators and Investigators

• Sponsor: Hugel

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: February 1, 2013

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: HG-11-01