A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss (NCT06961305) | Clinical Trial Compass
CompletedNot Applicable
A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss
Poland, Ukraine69 participantsStarted 2021-08-10
Plain-language summary
This post-marketing, prospective, multicentre, single-arm, open-label clinical investigation aimed to evaluate the safety, tolerability, and effectiveness of the injectable medical device Alexa Medium (based on cross-linked hyaluronic acid) for the correction of lip volume loss. Participants received one or two injections of the product, and effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS) and the Medicis Lip Fullness Scale (MLFS). Safety data were collected at each visit. The study demonstrated high effectiveness and safety, with most subjects achieving their personal aesthetic goals.
Who can participate
Age range
25 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:
* Subject's age 25 to 70.
* Subject will receive an injection of the medical device 'Alexa Medium' manufactured by Diaco Biofarmaceutici S.r.l., Italy for correction of the lips volume loss within accepted cosmetological practice.
* Subject's lips requiring correction of the lips volume loss according to the Investigator's judgement.
* The subject has established a realistic aesthetic improvement goal that the Investigator agrees is achievable, i.e., have realistic expectations of aesthetic results.
* Subject willing to have photographs of the face taken.
* Subject psychologically able to understand the Investigation related information and to give a written informed consent.
* Subject able and agreeing to follow Investigation procedures, instructions and likely to complete all required visits.
* The subject agreed to participate in the Investigation and signed the Informed Consent Form.
Exclusion Criteria:
* Subject's age less than 25 or more than 70.
* Subject tends to develop hypertrophic scarring.
* Subjects has known hypersensitivity to cross-linked hyaluronic acid.
* Subjects has history of severe and/or multiple allergies.
* Subjects has history of herpetic rash.
* Subject has impaired haemostatic function.
* Subject is on anticoagulant medication(s) or is using substances that can prolong bleeding.
* Subject has present or past history of autoimmune disease or autoimmune deficiency.
* Subject is undergoing immunosuppressive therapy.
* Subject ha…
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
Global Aesthetic Improvement Scale (GAIS) Score at Day 60