Glabellar Frown Lines
Conditions
Keywords
Glabellar Lines, Botulinum toxin, Botulinum toxin type A
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®.
Sponsors
Protox Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II) | 12 weeks after the injection |
| 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 |
Countries
South Korea
Outcome results
None listed