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OpenTrials
Completed

NCT Number: NCT01791920

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hopspital, Seoul, Dongjak-gu, South Korea

Loading trial locations.

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 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

Treatment and study plan

Botulinum toxin type A(Botulax®)

Drug

Single administration, Day 0, 20 units

Botulinum toxin type A(Botox®)

Drug

Single administration, Day 0, 20units

Primary outcomes

  1. Responder rate of improvement in glabellar lines with Physician's rating of line severity

    Time frame: at 4 weeks post-injection

    Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.

Secondary outcomes

  1. Safety evaluation in experimental drug treatment group

    Time frame: 4, 8, 12, 16 weeks post-injection

  2. Responder rate of improvement in glabellar lines with Physician's rating of line severity

    Time frame: 8, 12, 16 weeks post-injection

    Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.

  3. Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity

    Time frame: 4, 8, 12, 16 weeks post-injection

    Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection

  4. Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment

    Time frame: 4, 8, 12, 16 weeks post-injection

    Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection

  5. Responder rate of improvement in glabellar lines at rest with investigator's photo assessment

    Time frame: 4, 8, 12, 16 weeks post inejection

    Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection

  6. Responder rate of improvement in glabellar lines with Subject's improvement assessment

    Time frame: 4, 8, 12, 16 weeks post-injections

    Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection

  7. Subject's satisfaction rate

    Time frame: 4, 8, 12, 16 weeks post-injection

    Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Feb 15, 2013
Registry last updated
Apr 15, 2022

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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