Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-12-31

Brief Summary

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This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency

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Detailed Description

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This study is Multicenter, Randomized, Subject \& Independent Evaluator-blind, Split-face, Medical Device Pivotal study to evaluate the efficacy and safety of injection with JTM102 as compared to Juvederm VOLUMA with Lidocaine for temporary restoring the mid-face volume

Conditions

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Mid Face Volume Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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JTM102

HA filler with lidocaine

Group Type EXPERIMENTAL

JTM102

Intervention Type DEVICE

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

Juverderm Voluma with Lidocaine

HA filler with lidocaine

Group Type ACTIVE_COMPARATOR

Juvederm VOLUMA with Lidocaine

Intervention Type DEVICE

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

Interventions

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JTM102

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

Intervention Type DEVICE

Juvederm VOLUMA with Lidocaine

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects who voluntarily agree to participate in this clinical trial.
* Adults aged 19 to 65 years.
* Subjects who desire temporary improvement of mid-face volume and whose Mid-face Volume Deficit Scale (MFVDS, 5-point scale) score for the mid-face volume restoration meets eligibility criteria
* Subjects who agree to discontinue all dermatological treatments or procedures for the face during the clinical trial period, including wrinkle improvement treatments such as fillers, botulinum toxin, laser therapy, chemical peels, and cosmetic surgeries, except for the investigational medical device application.
* Subjects who use medically acceptable contraception methods throughout the clinical trial period (pregnant or breastfeeding women are excluded).
* Subjects who understand and can comply with the study instructions and can participate for the entire duration of the clinical trial.

Exclusion Criteria

* Use of medications that may affect evaluation of the investigational device:
* Any other conditions judged by the investigator as inappropriate for participation in this clinical trial.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No