Mid-face Volume DeficiencyNCT06034522
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl
A study testing Adipearl in people with Mid-face Volume Deficiency, run by Volumina Medical S.A. at 1 site in Sweden.
Trial summary
Adipearl is an injectable filler intended to be injected subcutaneously in the face. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mid-face Volume Deficiency
- What is being tested?
- Adipearl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 25 Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject having given freely and expressly informed consent;
- Subject deemed by the Investigator to be medically fit for injection of the product;
- Female or male subjects aged 22 to 65 years (inclusive);
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject participating to another research study.
- Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects
Adipearl is an injectable filler intended to be injected subcutaneously in the face.
- Conditions
- Mid-face Volume Deficiency
- Being tested
- Adipearl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdipearlDevice
Injection of the investigational device in the face.
| Study group | Role | What they receive |
|---|---|---|
| Face correction with Investigational device | Experimental | Subjects will be injected with the investigational device in the face. Receives: Device: Adipearl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Investigational Medical Device
Collection of Injection Site Reactions and Adverse Events during the study.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start25 Nov 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-face Volume DeficiencyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volumina Medical S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034522
- Sponsor's protocol ID
- DOC0478
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects
- ClinicalTrials.gov ID
- NCT06034522
- Acronym / sponsor ID
- DOC0478
- Conditions
- Mid-face Volume Deficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Volumina Medical S.A.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Sep 2023 (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.
Adipearl is an injectable filler intended to be injected subcutaneously in the face.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Face correction with Investigational device | Experimental | Device: AdipearlSubjects will be injected with the investigational device in the face. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject having given freely and expressly informed consent;
- Subject deemed by the Investigator to be medically fit for injection of the product;
- Female or male subjects aged 22 to 65 years (inclusive);
Key exclusion criteria (4 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject participating to another research study.
- Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
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 |
|---|---|---|
| AdipearlInjection of the investigational device in the face. | Device | Face correction with Investigational device |
Primary outcome
Safety of Investigational Medical Device
Time frame: Up to 6 months
Collection of Injection Site Reactions and Adverse Events during the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipearl in people with Mid-face Volume Deficiency, run by Volumina Medical S.A. at 1 site in Sweden.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety of Investigational Medical Device (time frame: Up to 6 months). 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 23 Sep 2025.