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

Jetema Co., Ltd.

Status: Not yet enrolling

Conditions: Nasolabial Folds, Wrinkles

Treatments: Biological: JTM104; Biological: Juvederm® ULTRA PLUS XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT07265791

JT-D-104-01

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 19 to 75 years
• Voluntarily provided written informed consent
• Moderate to severe symmetrical nasolabial folds (WSRS score 3 or 4 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

JTM104

Experimental group

Description:

HA Filler

Treatment:

Biological: JTM104

Juvederm® ULTRA PLUS XC

Active Comparator group

Description:

HA Filler

Treatment:

Biological: Juvederm® ULTRA PLUS XC