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

ATGC Co., Ltd.

Status and phase

Active, not recruiting

Phase 3

Conditions

Glabellar Frown Lines

Treatments

Biological: ATGC-110

Biological: Xeomin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT05623410

CBAP-PLN-002

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

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