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Active, not recruiting Not applicable

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

NCT07265778 · tracked via the Priya Life Science South Korea tracker
Sponsor
Jetema Co., Ltd
Phase
Not applicable
Started
2024-10-22
Last updated
2026-07-24

Condition(s) studied

Mid Face Volume Deficit

Investigational drug(s) / intervention(s)

JTM102Juvederm VOLUMA with Lidocaine

JTM102: Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%

Juvederm VOLUMA with Lidocaine: Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Chungang University Hospital Seoul South Korea

More Jetema Co., Ltd. trials in South Korea

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265778 on ClinicalTrials.gov ↗ ← All trials in South Korea