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

Moderate to Severe Glabellar Lines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970876
• Other study ID #: CBA-PLN-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 19, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: April 2019
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 23, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Moderate to Severe Glabellar Lines

Intervention

Biological:
• ATGC-100
Clostridium Botulinum Type A
• Botox®
Clostridium Botulinum Type A

Locations

Country	Name	City	State
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)		Up tp 12 weeks
Primary	Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)		4 weeks after the injection
Secondary	Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)		8, 12 weeks after the injection
Secondary	Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II)		4, 8, 12 weeks after the injection
Secondary	Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II)		4, 8, 12 weeks after the injection
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)		Up tp 12 weeks