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

Jetema Co., Ltd.

Status: Active, not recruiting

Conditions: Mid Face Volume Deficit

Treatments: Device: JTM102; Device: Juvederm VOLUMA with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07265778

JT-D-102-01

Details and patient eligibility

About

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

Full 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

Enrollment: 149 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

149 participants in 2 patient groups

JTM102

Experimental group

Description:

HA filler with lidocaine

Treatment:

Device: JTM102

Juverderm Voluma with Lidocaine

Active Comparator group

Description:

HA filler with lidocaine

Treatment:

Device: Juvederm VOLUMA with Lidocaine