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

NCT03970876 | Completed Phase 1

• 1 other identifier: CBA-PLN-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

ATGC-100 (Phase I/II)

EXPERIMENTAL

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

Biological: ATGC-100

Botox® (Phase II)

ACTIVE COMPARATOR

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

Biological: Botox®

Interventions

ATGC-100 BIOLOGICAL

Clostridium Botulinum Type A

ATGC-100 (Phase I/II)

Botox® BIOLOGICAL

Clostridium Botulinum Type A

Botox® (Phase II)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females aged between 19 to 65 years old
• Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
• Subjects who voluntarily signed the informed consent

You may not qualify if:

• Subjects with general neuromuscular synaptic disorders
• Presence or history of eyelid and/or ptosis
• Subjects with noticeable facial asymmetry
• Inability to substantially lessen glabellar frown lines even by physically spreading apart
• 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
• Subjects who are taking Anti-Coagulant and Anti-Platelet agent
• Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
• Subjects with skin disorders at the injection site
• Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
• Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
• Any other planned facial aesthetic procedure in the glabellar area during the trial period
• Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
• A history of drug or alcohol abuse
• Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion

Sponsors & Collaborators

• EuBiologics Co.,Ltd: lead

Study Sites (1)

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: April 19, 2019
• Primary Completion: September 11, 2019
• Study Completion: December 23, 2019
• Last Updated: March 23, 2021

Record last verified: 2019-04

Locations

KR (1)