Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds

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

Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds

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

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