None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Only subjects determined to be eligible at Visit 1 (Screening) and Visit 2 (Baseline) will be administered the investigational product at Visit 2 (Baseline). A 30
Sponsors
GENETOX Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older and under 65 years at Visit 1 (Screening) 2. Subjects with a Facial Wrinkle Scale (FWS) score of 2 (moderate) or higher at maximum frown, as assessed by the investigator at both Visit 1 (Screening) and Visit 2 (Baseline) 3. Subjects who agree to participate in the clinical trial and voluntarily sign the informed consent form 4. Ability to understand and comply with the clinical trial procedures and visit schedule
Exclusion criteria
Exclusion criteria: 1. 'Yes' to any question in the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire 2. Subjects with infection, skin disease, or scarring at the injection site 3. Subjects for whom improvement is difficult due to facial structural or physical factors, such as significant facial asymmetry, ptosis, excessive skin laxity, deep skin wounds, or thick seborrheic skin 4. Subjects with glabellar lines that do not smooth out even when physically manipulated, such as when wrinkles are not smoothed out by hand 5. Subjects with neuromuscular junction disorders, such as myasthenia gravis, Lambert-Eaton myasthenic syndrome, or amyotrophic lateral sclerosis 6. Subjects with a history of bleeding disorders, such as hemophilia, blood coagulation disorders, thrombocytopenia, or platelet function disorders 7. Subjects with a medical history of drug or alcohol addiction 8. Subjects with comorbid conditions deemed unsuitable for clinical trial participation by the investigator, such as severe cardiovascular disease, renal disease, hepatic disease, respiratory disease, psychiatric disorders, malignancies, or immunodeficiency 9. Subjects who have received botulinum toxin products within 6 months prior to Visit 1 (Screening) or are expected to receive botulinum toxin products during the clinical trial period 10. Subjects who have taken medications with muscle-relaxing effects within 4 weeks prior to Visit 1 (Screening), including muscle relaxants, aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincosamide antibiotics, anticholinergics, benzodiazepines and related drugs, or benzamides 11. Subjects who have received anticoagulants, antiplatelet agents, systemic non-steroidal anti-inflammatory drugs (NSAIDs), or vitamin E supplements exceeding 1,000 mg/day within 7 days prior to investigational product administration [However, low-dose aspirin (not more than 100 mg/day) administered for antithrombotic purposes is permitted.] 12. Subjects who have undergone or are scheduled to undergo surgeries or procedures that may affect the efficacy evaluation of the glabellar or forehead area during the following period 1) Within 6 months prior to Visit 1 (Screening): Facial cosmetic treatments or surgeries, such as tissue augmentation, brow lift, dermal resurfacing, chemical peeling/dermabrasion, or dermal photorejuvenation 2) Collagen-based dermal filler procedures within 4 months prior to Visit 1 (Screening), hyaluronic acid fillers within 12 months, hydroxyapatite fillers within 18 months, or polylactic acid/polycaprolactone fillers within 24 months 3) Prior to Visit 1 (Screening): Facial plastic surgery, implants, non-biodegradable dermal fillers, or fat grafting 4) Subjects who are scheduled to undergo facial cosmetic treatments or surgeries (including dermal fillers, photorejuvenation, chemical peeling/derma-brasion, or facial plastic surgery) during the clinical trial period 13. Subjects who have received retinoid drugs (such as isotretinoin or alitretinoin) during the following period 1) Within 6 months prior to Visit 1 (Screening): Oral or other systemic formulations 2) Within 3 months prior to Visit 1 (Screening): Topical formulations applied to the face, including retinol-containing cosmetics 14. Subjects with a history of allergy or hypersensitivity to components of the investigational product, including botulinum toxin products and serum albumin 15. Pregnant or lactating women, subjects planning to become pregnant during
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement rate of glabellar lines at maximum frown at Week 4 after investigational product administration, as assessed by the investigator on-site | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement rate of glabellar lines at maximum frown at Weeks 8, 12, and 16 after investigational product administration, as assessed by the investigator on-site;The improvement rate of glabellar lines at rest at Weeks 4, 8, 12, and 16 after investigational product administration, as assessed by the investigator on-site ;The improvement rate of glabellar lines at maximum frown at Weeks 4, 8, 12, and 16 after investigational product administration, as assessed by the independent reviewer’s photographic evaluation; The improvement rate of glabellar lines at rest at Weeks 4, 8, 12, and 16 after investigational product administration, as assessed by the independent reviewer’s photographic evaluation;The improvement rate of glabellar lines at Weeks 4, 8, 12, and 16 after investigational product administration, as assessed by the subject’s evaluation;The subject satisfaction rate at Weeks 4, 8, 12, and 16 after investigational product administration | — |
Countries
Korea, Republic of
Contacts
Public Contactbeomjoon kim
Chung-Ang Univerisity Hospital
Outcome results
None listed