Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT05623410

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

Conditions: Glabellar Frown Lines

Sex: All
Ages: 19 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 300
Sponsor: ATGC Co., Ltd.

Location: Korea, Republic of

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.

Eligibility Criteria

Inclusion Criteria:Male and female subjects aged between 19 to 65 yearsSubjects assigned a glabellar line severity grade of 2 or greater (moderate) at maximum frown assessed by the InvestigatorSubjects who provide written consent to voluntarily participate in the study after receiving and understanding a detailed explanation of the studyExclusion 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 ptosisSubjects with significant facial asymmetrySubjects whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using handsInfection, dermatological condition or scar at the treatment injection sitesSubjects currently suffering acute diseasesSubjects with the history of excessive alcohol consumption or drug addictionCondition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinionSubjects 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 diseaseSubjects with the history of treatment of the glabellar region (including the forehead) such as face lifting, permanent implants, or fillersSubjects 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 fillersSubjects 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 antibioticsSubjects 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 screeningSubjects 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 componentsSubjects who have received botulinum toxin preparations within 6 months from the time of screeningFemale 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 womenSubjects planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study periodSubjects 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 studiesSubjects 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05623410). StuddyBuddy aggregates publicly available trial information.