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

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.

NCT Number	NCT06961305
Lead Sponsor	Institute Hyalual GmbH
Conditions	Lip Volume Enhancement, Lip Augmentation, Aesthetic
Enrollment	69 participants
Start Date	2021-08-10
Primary Completion	2022-06-02 (estimated)
Study Completion	2022-06-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-06