A Phase I/II Randomized, Double Blind, Active-controlled, Single Center Clinical Trial for Evaluation of Safety and Efficacy of ATGC-110, An Intramuscularly Administered Clostridium Botulinum Neurotoxin Type A, in Adult Patients With Moderate to Severe Glabellar Frown Lines
A Phase I/II Randomized, Double Blind, Active-controlled, Single Center Clinical Trial for Evaluation of Safety and Efficacy of ATGC-110, An Intramuscularly Administered Clostridium Botulinum Neurotoxin Type A, in Adult Patients With Moderate to Severe Glabellar Frown Lines
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Botox for a total of 12 weeks after the administration in treatment of glabellar frown lines.
Inclusion Criteria:
Exclusion Criteria:
Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy
Subjects with the history of eyelid paralysis or ptosis
Subjects with significant facial asymmetry
Individuals whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
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 taking anticoagulants or antiplatelet agents (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed)
Subjects who have received aspirin or NSAIDs within 7 days prior to administration of the IP.
Subjects with skin abnormalities such as infection at the injection site, dermatopathy, or scars.
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:
Individuals planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study period.
Individuals who have received a botulinum toxin preparation within 5 months prior to screening or those who are expected to receive a botulinum toxin preparation for any other purpose than the indication of this study (glabellar lines).
Subjects with the history of excessive alcohol consumption or drug addiction
Individuals with an anxiety disorder or other significant psychiatric disorders (e.g., depression), which, in the Investigator's opinion, may affect study participation or objective assessment of efficacy outcomes
Individuals who answered "yes" to any of the questions on the Columbia University Suicide Severity Rating Scale (C-SSRS) regarding a case within the past 12 months at the 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 who are allergic or sensitive to the IP or its components
Individuals 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
Individuals who have participated in other clinical trials within 3 months prior to participating in this study and have received an IP or medical device during the previous clinical studies
Individuals who are not eligible for this study for any reason as per the Investigator's discretion