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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
This intervention involves the injection of Alexa Medium, a sterile, cross-linked hyaluronic acid gel (17.5 mg/mL). The gel is administered into the mucous membrane of the lips for aesthetic restoration of lip volume loss. The product is supplied in a pre-filled 1 mL syringe and injected by a trained medical professional. One or two injections were administered per participant, with the second injection performed at the investigator's discretion at Visit 2. The device is manufactured by Diaco Biofarmaceutici S.r.l., Italy.
Provita Sp. z o.o.
Katowice, Poland
Ośrodek medyczny OSTEOMED s.c.
Krakow, Poland
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, Poland
Institute Hyalual LLC
Kyiv, Ukraine
Global Aesthetic Improvement Scale (GAIS) Score at Day 60
Change in GAIS score from baseline to Day 60, as evaluated by the Investigator. GAIS is a 5-point scale ranging from 1 (exceptional improvement) to 5 (worsened patient).
Time frame: Day 60 ±5 days
Medicis Lip Fullness Scale (MLFS) Score at Day 60
hange in MLFS score from baseline to Day 60, as evaluated by the Investigator. MLFS is a 5-grade scale (1=very thin lips, 5=very full lips)
Time frame: Day 60 ±5 days
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