Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss (NCT06984419) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss
Poland, Ukraine68 participantsStarted 2021-06-29
Plain-language summary
This is a post-marketing, open-label, non-comparative, multi-center clinical investigation to evaluate the effectiveness and safety of the medical device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy), based on cross-linked hyaluronic acid, for the correction of midface volume loss. The study involved 68 female subjects across Poland and Ukraine who received Alexa Volume injections in the midface area. Effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and Medicis Midface Volume Scale (MMVS). The study demonstrated statistically significant improvements in aesthetic outcomes and confirmed a favorable safety profile with minimal adverse events
Who can participate
Age range
25 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:
* Twenty-five (25) years of age or older at time of consent.
* Desire and willingness for correction or enhancement of his/her mid-face area.
* Subjects presenting with loss of volume and contour of the midface area 2 or more score according to MMVS bilaterally.
* Nasolabial folds severity grade 2 or more according to WSRS bilaterally.
* Treatment-naive subjects for fillers in the areas to be treated in the last 12 months, otherwise as decided by the Investigator.
* Subjects with signed informed consent and photo consent.
* Medical history and physical examination which, based on the Investigator's opinion, do not prevent the subject from taking part in the investigation and use the investigational medical device (IMD).
* Subjects not pregnant, non-breastfeeding.
* Subject must be willing to complete the entire course of the investigation.
Exclusion Criteria:
* Pregnant, planning pregnancy during the investigation or breastfeeding women.
* Subjects with known hypersensitivity to any compound of the IMD.
* Subjects with history of any other adverse effect, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
* Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the injected area, including permanent fillers, that may interfere with the results.
* Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator …
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
Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3).
Timeframe: 28 days (from baseline Visit 1 to Visit 3)