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

Glabellar Frown Lines Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04996810
• Other study ID #: PT_BTA_P1_20
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 10, 2020
• Est. completion date: May 26, 2021

Study information

• Verified date: August 2021
• Source: Protox Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 26, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• PROTOXIN
Botulinum toxin Type A
• Botox®
Botulinum toxin Type A

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Protox Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)		12 weeks after the injection
Primary	Glabellar line improvement rate confirmed with investigator's assessment (Phase II)		4 weeks after the injection
Secondary	Glabellar line improvement rate confirmed with investigator's assessment (Phase II)		4, 8, 12 weeks after the injection
Secondary	Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)		4, 8, 12 weeks after the injection
Secondary	Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)		12 weeks after the injection