AestheticNCT06984419
Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss
A study testing Cross-linked hyaluronic acid dermal filler in people with Aesthetic and Aesthetic Rejuvenation, run by Institute Hyalual GmbH at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aesthetic, Aesthetic Rejuvenation, Midface Volumization
- What is being tested?
- Cross-linked hyaluronic acid dermal filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 Jun 2021to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites
Silmedic Sp. z o.o.
Katowice, 40-282
Provita Sp. z o.o.
Katowice, 40-611
Ośrodek Medyczny Osteomed s.c.
Krakow, 30-074
About this study
Official title: 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
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
Read the 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
- Being tested
- Cross-linked hyaluronic acid dermal filler
- Keywords
- Age-related, midface, volume, facial aesthetic, Alexa Volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-linked hyaluronic acid dermal fillerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Cross-linked hyaluronic acid dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days (from baseline Visit 1 to Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start29 Jun 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute Hyalual GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984419
- Sponsor's protocol ID
- D/Alexa.Vol.-2021
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06984419
- Acronym / sponsor ID
- D/Alexa.Vol.-2021
- Conditions
- Aesthetic, Aesthetic Rejuvenation, Midface Volumization, Age-related Volume Deficit in the Mid-face
- Keywords
- Age-related, midface, volume, facial aesthetic, Alexa Volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Institute Hyalual GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alexa Volume Treatment Arm | Experimental | Device: Cross-linked hyaluronic acid dermal fillerParticipants 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). |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-linked hyaluronic acid dermal fillerAlexa 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. | Device | Alexa Volume Treatment Arm |
Primary outcome
Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3).
Time frame: 28 days (from baseline Visit 1 to 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-linked hyaluronic acid dermal filler in people with Aesthetic and Aesthetic Rejuvenation, run by Institute Hyalual GmbH at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3). (time frame: 28 days (from baseline Visit 1 to Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.