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. 2021 Jul 5;2021(7):CD011301. doi: 10.1002/14651858.CD011301.pub2

NCT02961673.

Methods Randomised, double‐blind (participants and investigator), active‐control, phase I/II trial
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
Participants 57 participants, older than 19 years old, both gender
Inclusion Criteria
  • Facial Wrinkle Scale (FWS) score > 2 when participant knits brow extremely


Exclusion Criteria
  • Volunteer who has history of any diseases following (myasthenia gravis, Eaton‐Lambert syndrome, amyotrophic lateral sclerosis etc.)

  • From screening, participant who received plastic surgery including fascioplasty, prosthesis implantation within 6 weeks

  • Participant who has skin disorder including infection and scar on injection site

  • Participant who takes a medication including skeletal muscle relaxants, aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.

  • Participant 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

Interventions Intervention
  • Iintramuscular injection of HU‐014 in the glabellar region, 5 glabellar points each 4 U/0.1 mL (Total 20 U/0. 5mL


Comparator:
  • Intramuscular injection of onabotulinumtoxinA in the glabellar region, 5 glabellar points each 4 U/0.1 mL Total 20 U/0.5 mL

Outcomes Primary outcomes
  • Assessment of Treatment‐Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product (Phase 1) [TimeFrame: Week 4]

  • Change from baseline of glabellar lines improvement rate(frown) [Time Frame: Week 4]


Secondary outcomes
  • Assessment of Columbia Suicide Severity Rating Scale(C‐SSRS) [Time Frame: Week 4, Week 8, Week 12]

  • Change from baseline of glabellar lines improvement rate (frown) [Time Frame: Week 8, Week 12]

  • Change from baseline of glabellar lines improvement rate (not frown) [Time Frame: Week4, Week 8, Week 12]

  • Efficacy outcome measure (Phase 2) by collecting Subject Satisfaction assessment [Time Frame: Week 4, Week 8, Week 12]

  • 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]

Notes Sponsor Huons Co., Ltd.
This trial finished on April 2018