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

• Sponsor: EuBiologics Co.,Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03970876
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Glabellar Lines	Biological: ATGC-100; Biological: Botox®	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
• Actual Study Start Date: Apr 19, 2019
• Actual Primary Completion Date: Sep 11, 2019
• Actual Study Completion Date: Dec 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATGC-100 (Phase I/II) ATGC-100 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)	Biological: ATGC-100; Clostridium Botulinum Type A
Active Comparator: Botox® (Phase II) Botox® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)	Biological: Botox®; Clostridium Botulinum Type A

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) [Up tp 12 weeks]

2. Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) [4 weeks after the injection]

Secondary Outcome Measures

1. Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) [8, 12 weeks after the injection]

2. Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II) [4, 8, 12 weeks after the injection]

3. Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II) [4, 8, 12 weeks after the injection]

4. Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II) [Up tp 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nowon Eulji Medical Center, Eulji University	Seoul		Korea, Republic of

Sponsors and Collaborators

• EuBiologics Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EuBiologics Co.,Ltd
• ClinicalTrials.gov Identifier: NCT03970876
• Other Study ID Numbers: CBA-PLN-001
• First Posted: Jun 3, 2019
• Last Update Posted: Mar 23, 2021
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 23, 2021