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

Protox

Status and phase

Completed

Phase 2

Phase 1

Conditions

Glabellar Frown Lines

Treatments

Biological: Botox®

Biological: PROTOXIN

Study type

Interventional

Funder types

Industry

Identifiers

NCT04996810

PT_BTA_P1_20

Details and patient eligibility

About

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®.

Enrollment

60 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

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