Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05623410
Other study ID # CBAP-PLN-002
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 11, 2022
Est. completion date June 10, 2023

Study information

Verified date February 2023
Source ATGC Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date June 10, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.
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.

Locations

Country Name City State
Korea, Republic of Nowon Eulji Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
ATGC Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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.
8, 12 and 16 weeks after the administration
Secondary 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 Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 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, 8, 12 and 16 weeks after the administration
Secondary 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 Independent evaluator 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, 8, 12 and 16 weeks after the administration
Secondary 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 Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 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, 8, 12 and 16 weeks after the administration
Secondary 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 Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. 4, 8, 12 and 16 weeks after the administration
Secondary The percentage of subjects whose FWS score is 0- or 1-grade at rest according to the investigator's on-site evaluation at week 4, 8, 12, and 16 Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. 4, 8, 12 and 16 weeks after the administration
Secondary The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16 Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. 4, 8, 12 and 16 weeks after the administration
Secondary The percentage of subjects whose FWS score is 0- or 1-grade at rest evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16 Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. 4, 8, 12 and 16 weeks after the administration
Secondary The percentage of subjects whose FWS score is improved = 2 grade improvement according to the subject's evaluation at week 4, 8, 12, and 16 Subjects will assess their glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe. 4, 8, 12 and 16 weeks after the administration
Secondary Evaluation of subjects' satisfaction at weeks 4, 8, 12, and 16 If the subject's satisfaction evaluation score is 6 points or higher, it is evaluated as satisfactory. 4, 8, 12 and 16 weeks after the administration
Secondary The percentage of subjects whose FWS score is imporved = 2 grade improvement at maximal frown according to the investigator's on-site and subject's evaluation at weeks 4, 8, 12, and 16 If the glabellar line score evaluated by the subject is +2 points or higher, it is evaluated as improved 4, 8, 12 and 16 weeks after the administration
See also
  Status Clinical Trial Phase
Completed NCT02236312 - Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines Phase 2
Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
Completed NCT00430963 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines Phase 3
Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
Completed NCT03687736 - Subject Satisfaction With AbobutulinumtoxinA Treatment Phase 4
Active, not recruiting NCT04281745 - Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® Phase 4
Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
Completed NCT03736928 - Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines Phase 2
Completed NCT01808742 - Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device N/A
Completed NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines Phase 3
Completed NCT00430586 - Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines Phase 2
Completed NCT04281095 - A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines Phase 1/Phase 2
Completed NCT05146999 - Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02428608 - Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 Phase 2
Completed NCT04143815 - Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines Phase 2
Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT05320393 - Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines Phase 2
Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3
Completed NCT01333397 - Safety and Efficacy Study of Dysport RU and Glabellar Lines Phase 2