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

NCT06984419 | Completed

• 1 other identifier: D/Alexa.Vol.-2021
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 4

Brief 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

Conditions

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

Keywords

Age-related; midface; volume; facial aesthetic; Alexa Volume

Outcome Measures

Primary Outcomes (1)

• Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3).

  The GAIS (Global Aesthetic Improvement Scale) is a 5-point ordinal scale used to assess improvement in facial aesthetics. The scale ranges from 1 (Very Much Improved) to 5 (Worse), where lower scores indicate better outcomes. Investigators evaluated standardized photographs taken before and after treatment. A reduction of ≥1 point from baseline was considered a clinically meaningful improvement.

  28 days (from baseline Visit 1 to Visit 3)

Study Arms (1)

Alexa Volume Treatment Arm

EXPERIMENTAL

Participants in this single treatment arm received subcutaneous or upper-periosteal injections of Alexa Volume, a CE-marked cross-linked hyaluronic acid gel, for the correction of midface volume loss. The initial injection was administered at Visit 1, with an optional additional correction at Visit 2 based on the Investigator's assessment. Effectiveness and safety evaluations were conducted through Visit 4 (Day 180).

Device: Cross-linked hyaluronic acid dermal filler

Interventions

Cross-linked hyaluronic acid dermal filler DEVICE

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.

Alexa Volume Treatment Arm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty-five (25) years of age or older at time of consent.
• Desire and willingness for correction or enhancement of his/her mid-face area.
• Subjects presenting with loss of volume and contour of the midface area 2 or more score according to MMVS bilaterally.
• Nasolabial folds severity grade 2 or more according to WSRS bilaterally.
• Treatment-naive subjects for fillers in the areas to be treated in the last 12 months, otherwise as decided by the Investigator.
• Subjects with signed informed consent and photo consent.
• Medical history and physical examination which, based on the Investigator's opinion, do not prevent the subject from taking part in the investigation and use the investigational medical device (IMD).
• Subjects not pregnant, non-breastfeeding.
• Subject must be willing to complete the entire course of the investigation.

You may not qualify if:

• Pregnant, planning pregnancy during the investigation or breastfeeding women.
• Subjects with known hypersensitivity to any compound of the IMD.
• Subjects with history of any other adverse effect, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
• Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the injected area, including permanent fillers, that may interfere with the results.
• Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the investigation.
• Subjects with active inflammation or infection in the areas of Alexa administration.
• Subjects with tattoo and/or scar in the area of Alexa Volume administration that in the Investigator's opinion would interfere with investigation assessments.
• Subjects who tend to develop hypertrophic scarring.
• Subjects with impaired hemostatic function, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
• Subjects with fibrosis, birthmark, or residual material in the area of intended use of Alexa Volume.
• Subjects participating in other clinical investigations within 30 days prior to the Visit 1.

Sponsors & Collaborators

• Institute Hyalual GmbH: lead

Study Sites (4)

Silmedic Sp. z o.o.

Katowice, 40-282, Poland

Location

Provita Sp. z o.o.

Katowice, 40-611, Poland

Location

Ośrodek Medyczny Osteomed s.c.

Krakow, 30-074, Poland

Location

Institute Hyalual LLC

Kyiv, 03151, Ukraine

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a non-comparative, open-label study where all subjects received subcutaneous or upper-periosteal injections of Alexa Volume according to standardized procedures under routine clinical (cosmetology) conditions. No control or placebo group was included, and all participants were followed over 180 days for aesthetic and safety outcomes.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 29, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

UA (1); PL (3)