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COMPLETED
NCT06961305
NA

A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss

Sponsor: Institute Hyalual GmbH

View on ClinicalTrials.gov

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

DEVICE

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