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

NCT ID: NCT07265791

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-03

Study Completion Date

2027-01-31

Brief Summary

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

Detailed Description

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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

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Nasolabial Folds, Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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JTM104

HA Filler

Group Type EXPERIMENTAL

JTM104

Intervention Type BIOLOGICAL

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.

Juvederm® ULTRA PLUS XC

HA Filler

Group Type ACTIVE_COMPARATOR

Juvederm® ULTRA PLUS XC

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jetema Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jetema_clinical

Role: CONTACT

+820317889520

Other Identifiers

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JT-D-104-01

Identifier Type: -

Identifier Source: org_study_id

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