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

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

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®.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: PROTOXIN; Biological: Botox®

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Nowon Eulji Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROTOXIN (Phase I/II); PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL).	Biological: PROTOXIN; Botulinum toxin Type A
Active Comparator: Botox® (Phase II); Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL).	Biological: Botox®; Botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Protox Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): April 2, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 8, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Botulinum toxin type A; Botulinum toxin; Glabellar Lines
• Other Study ID Numbers: PT_BTA_P1_20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No