Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines

NCT05623410 | Unknown Phase 3

• 1 other identifier: CBAP-PLN-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown lines.

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline

  Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.

  4 weeks after the administration

Secondary Outcomes (11)

• Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at weeks 8, 12, and 16 compared to the baseline

  8, 12 and 16 weeks after the administration

• Improvement rate (%) of glabellar lines at rest according to the investigator's on-site evaluation at weeks 4, 8, 12, and 16 compared to the baseline

  4, 8, 12 and 16 weeks after the administration

• Improvement rate (%) of glabellar lines at maximum frown evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline

  4, 8, 12 and 16 weeks after the administration

• Improvement rate (%) of glabellar lines at rest evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline

  4, 8, 12 and 16 weeks after the administration

• The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown according to the investigator's on-site evaluation at week 4, 8, 12, and 16

  4, 8, 12 and 16 weeks after the administration

Study Arms (2)

Botulinum toxin type A(ATGC-110)

EXPERIMENTAL

ATGC-110 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)

Biological: ATGC-110

Incobotulinumtoxin A (Xeomin®)

ACTIVE COMPARATOR

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

Biological: Xeomin®

Interventions

ATGC-110 BIOLOGICAL

ATGC-110 is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.

Also known as: Clostridium Botulinum Type A

Botulinum toxin type A(ATGC-110)

Xeomin® BIOLOGICAL

Xeomin® is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.

Also known as: Incobotulinumtoxin A

Incobotulinumtoxin A (Xeomin®)

Eligibility Criteria

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

You may qualify if:

• Male and female subjects aged between 19 to 65 years
• Subjects assigned a glabellar line severity grade of 2 or greater (moderate) at maximum frown assessed by the Investigator
• Subjects who provide written consent to voluntarily participate in the study after receiving and understanding a detailed explanation of the study

You may not qualify if:

• Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy etc.)
• Subjects with the history of eyelid paralysis or ptosis
• Subjects with significant facial asymmetry
• Subjects whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
• Infection, dermatological condition or scar at the treatment injection sites
• Subjects currently suffering acute diseases
• Subjects with the history of excessive alcohol consumption or drug addiction
• Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion
• Subjects with concomitant illnesses that make them unsuitable for participation in the study by the Investigator such as malignant tumors, immunodeficiency (immune deficiency), kidney disease, liver disease, or lung disease
• Subjects with the history of treatment of the glabellar region (including the forehead) such as face lifting, permanent implants, or fillers
• Subjects who have received other procedures that may affect the assessment of the glabellar or forehead lines during the following periods; Within 6 months of screening: main ingredient hyaluronic acid skin filler, dermal resurfacing, chemical/mechanical skin peeling, skin peeling, Dermal photorejuvenation; Within 12 months of screening: Dermal fillers other than the main ingredient hyaluronic acid, nonpermanent soft tissue fillers
• Subjects who have received medication that inhibits neuromuscular function within the 4 weeks prior to screening such as muscle relaxants, anticholinergics, benzodiazepines and similar drugs, benzamides, tetracycline antibiotics, lincomycin antibiotics, and aminoglycoside antibiotics
• Subjects who have taken retinoid drugs (Isotretinoin, Alitretinoin, etc.) during the following period; Oral and systemic use: within 6 months of screening Topical applied on the face: within 3 months of screening
• Subjects who have received aspirin or NSAIDs within 7 days prior to administration of the IP (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed).
• Subjects taking anticoagulants or antiplatelet agents (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed)

Sponsors & Collaborators

• ATGC Co., Ltd.: lead

Study Sites (1)

Nowon Eulji Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: October 11, 2022
• Primary Completion: February 10, 2023
• Study Completion: June 10, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)