A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds (NCT07467239) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
Spain30 participantsStarted 2026-03-02
Plain-language summary
This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
Who can participate
Age range
18 Years – 70 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:
* Men and women aged 18-70 years.
* Score of 3 to 4 on the Wrinkle Severity Rating Scale (WSRS) for both nasolabial folds.
* Willing and able to provide written informed consent.
* Willing to comply with study procedures and follow-up visits.
* Willing to refrain from other facial cosmetic procedures affecting the nasolabial folds during the study.
Exclusion Criteria:
* Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or planned use within 2 weeks after treatment.
* History or presence of bleeding disorders.
* Participation in another clinical investigation within 1 month prior to screening.
* Pregnant or breastfeeding women, or women planning pregnancy during the study.
* Women of childbearing potential not using an effective method of contraception.
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
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating Investigator (EI)