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 range25 Years – 70 Years
SexALL
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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…
What they're measuring
1
Global Aesthetic Improvement Scale (GAIS) Score at Day 60