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NCT Number: NCT07265778

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mid Face Volume Deficit

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungang University Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria
  • History of procedures (including surgery) included in 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.

Treatment and study plan

JTM102

Device

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

Juvederm VOLUMA with Lidocaine

Device

Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

Primary outcomes

  1. Improvement in midface volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jetema Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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