Moderate to Severe Glabellar Lines
Conditions
Brief summary
Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).
Interventions
BIOLOGICALATGC-100
Clostridium Botulinum Type A
BIOLOGICALBotox®
Clostridium Botulinum Type A
Sponsors
EuBiologics Co.,Ltd
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
1. Healthy males and females aged between 19 to 65 years old 2. Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown 3. Subjects who voluntarily signed the informed consent
Exclusion criteria
1. Subjects with general neuromuscular synaptic disorders 2. Presence or history of eyelid and/or ptosis 3. Subjects with noticeable facial asymmetry 4. Inability to substantially lessen glabellar frown lines even by physically spreading apart 5. Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics 6. Subjects who are taking Anti-Coagulant and Anti-Platelet agent 7. Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug 8. Subjects with skin disorders at the injection site 9. Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region 10. Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment 11. Any other planned facial aesthetic procedure in the glabellar area during the trial period 12. Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period 13. A history of drug or alcohol abuse 14. Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) | Up tp 12 weeks |
| Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) | 4 weeks after the injection |
Secondary
| Measure | Time frame |
|---|---|
| Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) | 8, 12 weeks after the injection |
| Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II) | 4, 8, 12 weeks after the injection |
| Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II) | 4, 8, 12 weeks after the injection |
| Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II) | Up tp 12 weeks |
Countries
South Korea
Outcome results
None listed