Nasolabial Folds, Wrinkles
Conditions
Brief summary
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Detailed description
Multicenter, Randomized, Subject & Independent Evaluator-blind, Matched pairs, Active-controlled, Non-inferiority, Pivotal study to evaluate the Efficacy and Safety of Injection with JTM104 as Compared to Juvederm® ULTRA PLUS XC in temporary correction of Moderate to Severe Nasolabial folds
Interventions
BIOLOGICALJTM104
JTM104 contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine.
BIOLOGICALJuvederm® ULTRA PLUS XC
Juvederm® ULTRA PLUS XC contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine.
Sponsors
Jetema Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 to 75 years * Voluntarily provided written informed consent * Moderate to severe symmetrical nasolabial folds (score 3 or 4 on a 5-point severity scale on both sides) * Agree to discontinue other facial dermatologic treatments (e.g., fillers, botulinum toxin, laser) during the study * Able to understand instructions and comply with study procedures
Exclusion criteria
* Untreated scars or facial skin infections/diseases affecting the mid/lower face within the past year * History of severe allergy or hypersensitivity to device components * Facial invasive procedures within the past 6 months (including surgery, laser, botulinum toxin) * Use of certain medications (anticoagulants, immunosuppressants, steroids) within specified washout periods * Participation in other interventional clinical trials within 4 weeks before screening or during study * Non-compliance with contraception requirements or pregnancy/lactation during study * Deemed unsuitable by investigator for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE | From adverse event onset through resolution or stabilization, up to 30 days post-study completion | Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved. |
| SAE | From adverse event onset through resolution or stabilization, up to 30 days post-study completion | Continuous follow-up of adverse events until resolution, stabilization, or cause identification; includes 30-day follow-up after study completion if unresolved. |
| Solicited local AE | Within 2 weeks after device application | Local adverse events occurring at the application site within 2 weeks after device use, including pain, swelling, redness, bruising, and other injection site reactions. |
Countries
South Korea
Outcome results
None listed