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

NCT ID: NCT05623410

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-06-10

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

Study Design

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

Study Groups

Botulinum toxin type A(ATGC-110)

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

Group Type: EXPERIMENTAL

ATGC-110

Intervention Type: 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.

Incobotulinumtoxin A (Xeomin®)

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

Group Type: ACTIVE_COMPARATOR

Xeomin®

Intervention Type: 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.

Interventions

ATGC-110

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.

Intervention Type: BIOLOGICAL

Xeomin®

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Clostridium Botulinum Type A; Incobotulinumtoxin A

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Subjects who are allergic or sensitive to the IP or its components
• Subjects who have received botulinum toxin preparations within 6 months from the time of screening
• Female subjects of childbearing age who do not agree to practice contraception using medically allowed contraceptive methods during the study period (hormonal contraception, IUD (intrauterine device) or IUS (intrauterine system), tubal ligation, dual protection (using a combination of male condom, female condom, cervical cap, contraceptive diaphragm, or contraceptive sponge)
• Pregnant or lactating women
• Subjects planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study period
• Subjects who have participated in other clinical trials within 30 days prior to participating in this study and have received an IP or medical device during the previous clinical studies
• Subjects directly related to the investigator (e.g. a dermatologist or plastic surgeon)
• Individuals who are not eligible for this study for any reason as per the Investigator's discretion

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

Sponsors

ATGC Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nowon Eulji Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CBAP-PLN-002

Identifier Type: -

Identifier Source: org_study_id