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

NCT04996810 | Completed Phase 1

• 1 other identifier: PT_BTA_P1_20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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®.

Conditions

Glabellar Frown Lines

Keywords

Glabellar Lines; Botulinum toxin; Botulinum toxin type A

Outcome Measures

Primary Outcomes (2)

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

  12 weeks after the injection

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

  4 weeks after the injection

Secondary Outcomes (3)

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

  4, 8, 12 weeks after the injection

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

  4, 8, 12 weeks after the injection

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

  12 weeks after the injection

Study Arms (2)

PROTOXIN (Phase I/II)

EXPERIMENTAL

PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL).

Biological: PROTOXIN

Botox® (Phase II)

ACTIVE COMPARATOR

Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL).

Biological: Botox®

Interventions

PROTOXIN BIOLOGICAL

Botulinum toxin Type A

PROTOXIN (Phase I/II)

Botox® BIOLOGICAL

Botulinum toxin Type A

Botox® (Phase II)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Protox Inc.: lead

Study Sites (2)

Chung-Ang University Hospital

Seoul, South Korea

Location

Nowon Eulji Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Beomjoon Kim

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: December 10, 2020
• Primary Completion: April 2, 2021
• Study Completion: May 26, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)