Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Defici… (NCT07265778) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency
South Korea149 participantsStarted 2024-10-22
Plain-language summary
This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MFVDS
Timeframe: 24 weeks after final application of the investigational medical device