NCT07265791

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jetema Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nasolabial Folds, Wrinkles

Interventions

Type	Name	Description
BIOLOGICAL	JTM104	JTM104 contains 22.8 mg/mL cross-linked hyaluronic acid, 1.2 mg/mL hyaluronic acid, and 3 mg/mL lidocaine. The product will be injected into the nasolabial folds, with a maximum volume of 1 mL per side.
BIOLOGICAL	Juvederm® 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. The product will be injected into the nasolabial folds, with a maximum volume of 1 mL per side.

Timeline

• Start date: 2026-01-03
• Primary completion: 2026-06-30
• Completion: 2027-01-31
• First posted: 2025-12-05
• Last updated: 2025-12-05