NCT06984419

Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss

A Post-marketing, Open-label, Non-comparative, Multi-center Investigation to Evaluate the Effectiveness and Safety of a Medical Device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy) Based on Cross-linked Hyaluronic Acid for Correction of the Midface Volume Los

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Institute Hyalual GmbH · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

This is a post-marketing, open-label, non-comparative, multi-center clinical investigation to evaluate the effectiveness and safety of the medical device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy), based on cross-linked hyaluronic acid, for the correction of midface volume loss. The study involved 68 female subjects across Poland and Ukraine who received Alexa Volume injections in the midface area. Effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and Medicis Midface Volume Scale (MMVS). The study demonstrated statistically significant improvements in aesthetic outcomes and confirmed a favorable safety profile with minimal adverse events

Detailed description

This clinical investigation evaluated the effectiveness and safety of the CE-marked medical device "Alexa Volume," a cross-linked hyaluronic acid filler, for correction of midface volume loss in adult subjects. Conducted at multiple centers in Poland and Ukraine, the open-label, non-comparative study collected post-marketing data under routine clinical conditions.

Conditions

• Aesthetic
• Aesthetic Rejuvenation
• Midface Volumization
• Age-related Volume Deficit in the Mid-face

Interventions

Type	Name	Description
DEVICE	Cross-linked hyaluronic acid dermal filler	Alexa Volume is a CE-marked, cross-linked hyaluronic acid dermal filler used for aesthetic correction of midface volume loss. It was administered subcutaneously or to the upper periosteum in adult female participants according to standardized procedures.

Timeline

• Start date: 2021-06-29
• Primary completion: 2022-03-14
• Completion: 2022-03-14
• First posted: 2025-05-22
• Last updated: 2025-06-05

Locations

4 sites across 2 countries: Poland, Ukraine