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Completed

NCT Number: NCT04996810

The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines

This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.

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Key information

Conditions

Glabellar Frown Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chung-Ang University Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women aged between 19 to 65 years old
  • Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
  • Fertile women who have properly agreed to contraception during the clinical trial period
  • Subjects who voluntarily sign the informed consent

Exclusion criteria

  • Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
  • Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
  • Subjects who suffer from muscle weakness or paralysis in the forehead area
  • Subjects with infection, skin disorders, or scars at the glabellar region.
  • Subjects with noticeable facial asymmetry
  • Subjects with allergy or hypersensitivity to the botulinum toxin or their components
  • Subjects who have taken Anti-Coagulant, Anti-Platelet agent, Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
  • Subjects who were injected facial with botulinum toxin within the past 6 months or whose dose exceeds 200 U for the whole body
  • Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in the glabellar region
  • Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks of the screening date.
  • A history of drug or alcohol abuse
  • Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
  • Subjects who are not eligible for this study based on the judgment of an investigator

Treatment and study plan

PROTOXIN

Biological

Botulinum toxin Type A

BOTOX®

Biological

Botulinum toxin Type A

Primary outcomes

  1. Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)

    Time frame: 12 weeks after the injection

  2. Glabellar line improvement rate confirmed with investigator's assessment (Phase II)

    Time frame: 4 weeks after the injection

Secondary outcomes

  1. Glabellar line improvement rate confirmed with investigator's assessment (Phase II)

    Time frame: 4, 8, 12 weeks after the injection

  2. Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)

    Time frame: 4, 8, 12 weeks after the injection

  3. Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)

    Time frame: 12 weeks after the injection

Sponsors and collaborators

Lead sponsor

Protox Inc.

Industry

Registry information

Official study title

A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
Aug 10, 2021

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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