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Completed

NCT Number: NCT02961673

The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines

A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines

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Key information

Conditions

Glabellar Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Huons

Seongnam-si, Gyeonggi-do, 13486, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely

Exclusion criteria

  • Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
  • From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
  • Subject who has skin disorder including infection and scar on injection site
  • Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
  • Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
  • Any condition that, in the view of the investigator, would interfere with study participation

Treatment and study plan

HU-014 Inj

Biological

Clostridium botulinum type A

Botox Inj

Biological

Clostridium botulinum type A

Primary outcomes

  1. Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)

    Time frame: Week 4

  2. Change from Baseline of Glabellar Lines improvement rate(Frown)

    Time frame: Week 4

Secondary outcomes

  1. Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)

    Time frame: Week 4, Week 8, Week 12

  2. change from Baseline of Glabellar Lines improvement rate (Frown)

    Time frame: Week 8, Week 12

  3. change from Baseline of Glabellar Lines improvement rate (Not frown)

    Time frame: Week4, Week 8, Week 12

  4. Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment

    Time frame: Week 4, Week 8, Week 12

  5. Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product

    Time frame: Week 4, Week 8, Week 12

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Apr 12, 2018

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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