Clinical trial NCT06961305: A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss
Official title: Post-Marketing, Prospective, Multicentre, Single-Arm, Open-Label Investigation of Alexa Medium for Correction of Lip Volume Loss Within Accepted Cosmetological Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Volume Enhancement
Lip Augmentation
Aesthetic
Keywords: Aesthetic
Lip Volume
Alexa Medium
Lead sponsor: Institute Hyalual GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 69
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 has acute rheumatic fever with heart complications.
* Subject has tumour in area of the IMD application.
* Subject has active tuberculosis.
* Subject with presence of any other chronic disease that in the opinion of the Investigator may interfere with the outcome of the Investigation.
* Subject is a pregnant or breastfeeding women.
* Subject is presenting with cutaneous inflammatory and/or infectious diseases (acne, herpes, etc.) in area of the IMD application.
* Subject plans laser correction, deep chemical peels or dermabrasion during the potential participation in this Investigation.
* Subject has undergone recently laser correction, deep chemical peels, dermabrasion or surface peels, so the inflammatory reaction from the peel is significant.
* Subject has a permanent implant in the area of the IMD application.
* Subject has already injected more than 18 mL of dermal fillers per 60 kg of body mass per year.
* Subject refuses or is suspected of inability to comply with the requirements of the CIP.
* Subject has difficulty understanding the language in which the informed consent is written.
* Any other reason that the Investigator believes prevents the subject from participating in the Investigation (including suspicion of body dysmorphic disorder).
* Subject takes part in the other Investigation.

Primary outcomes:
measure: Global Aesthetic Improvement Scale (GAIS) Score at Day 60
timeFrame: Day 60 ±5 days
measure: Medicis Lip Fullness Scale (MLFS) Score at Day 60
timeFrame: Day 60 ±5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Provita Sp. z o.o.
city: Kraków
country: Poland
facility: Ośrodek medyczny OSTEOMED s.c.
city: Ostrowiec Świętokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne
city: Kyiv
country: Ukraine
facility: Institute Hyalual LLC
Study officials:
References: