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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07265778

Enrollment

149

Registered

2025-12-05

Start date

2024-10-22

Completion date

2027-02-27

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mid Face Volume Deficit

Keywords

mid-face volume, HA filler

Brief summary

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

Detailed description

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

Interventions

DEVICEJTM102

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

DEVICEJuvederm VOLUMA with Lidocaine

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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 level 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

* History or concurrent conditions included in

Design outcomes

Primary

Measure	Time frame	Description
Improvement in midface volume	24 weeks after final application of the investigational medical device	Facial volume deficiency was graded using 6-point Facial Midvolume Measuring Scale with higher scores indicating greater severity of gauntness. The proportion of subjects whose score decreased from baseline, as assessed by independent photographic evaluators, was calculated.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026