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

NCT ID: NCT04996810

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2021-05-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PROTOXIN (Phase I/II)

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

Group Type: EXPERIMENTAL

PROTOXIN

Intervention Type: BIOLOGICAL

Botulinum toxin Type A

Botox® (Phase II)

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

Group Type: ACTIVE_COMPARATOR

Botox®

Intervention Type: BIOLOGICAL

Botulinum toxin Type A

Interventions

PROTOXIN

Botulinum toxin Type A

Intervention Type: BIOLOGICAL

Botox®

Botulinum toxin Type A

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Protox Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beomjoon Kim

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Nowon Eulji Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PT_BTA_P1_20

Identifier Type: -

Identifier Source: org_study_id