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A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss
Sponsor: Institute Hyalual GmbH
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.
Official title: Post-Marketing, Prospective, Multicentre, Single-Arm, Open-Label Investigation of Alexa Medium for Correction of Lip Volume Loss Within Accepted Cosmetological Practice
Key Details
Gender
All
Age Range
25 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2021-08-10
Completion Date
2022-06-02
Last Updated
2026-05-06
Healthy Volunteers
Yes
Interventions
Cross-linked Hyaluronic Acid Gel
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.
Locations (4)
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