Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

NCT ID: NCT03970876

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2019-12-23

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).

Conditions

Moderate to Severe Glabellar Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ATGC-100 (Phase I/II)

ATGC-100 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)

Group Type: EXPERIMENTAL

ATGC-100

Intervention Type: BIOLOGICAL

Clostridium Botulinum Type A

Botox® (Phase II)

Botox® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)

Group Type: ACTIVE_COMPARATOR

Botox®

Intervention Type: BIOLOGICAL

Clostridium Botulinum Type A

Interventions

ATGC-100

Clostridium Botulinum Type A

Intervention Type: BIOLOGICAL

Botox®

Clostridium Botulinum Type A

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CBA-PLN-001

Identifier Type: -

Identifier Source: org_study_id