Midface Volume DeficitDAG-VOLNCT06565988
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma
A study testing Decoria Voluma in people with Midface Volume Deficit, run by Bohus Biotech AB at 7 sites in Sweden.
Trial summary
A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Midface Volume Deficit
- What is being tested?
- Decoria Voluma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 7 sitesSweden
- Study dates
- 2 Sep 2024to 26 Sep 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years, males and females.
- Able and willing to give written informed consent for participation in the investigation.
- Treating investigator considers the subject's cheeks amenable to an improvement of at least 1 grade on the GAIS. At least one side of face should either have a potential to enhance cheek volume or have moderate to severe cheek volume deficit. The grades do not have to be the same on both sides.
- Ability to follow study instructions and likely to complete all required visits.
Who cannot join
- Pregnant or lactating females.
- Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
- Any corrective procedures performed or planned in the midface region (e.g., silicone implants, permanent fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, dental implants) that may confound the evaluation of safety and performance of the IMD.
- Any other intradermal injection, such as semi-permanent fillers or botulinum toxin (no complications are allowed), received in the same injection area within 12 months of the Treatment visit (Visit 1) that may confound the evaluation of safety and performance of the IMD.
- Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
- Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
Show all 12Show fewer
- Has any treatments (thrombolytics, anticoagulants) or disease related to the coagulation system.
- Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
- Patients receiving interferon and ribavirin treatment.
- Features that may interfere with the visual assessment such as recent cosmetic treatment,scarring, abscess, piercing or tattoo.
- Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
- Employees of the study site or the sponsor directly involved with the conduct of the investigation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Inskinity
Gothenburg, 411 07
Göteborgs Laser & Estetik
Gothenburg, 411 08
Svenska Hudkliniker
Karlstad, 652 25
Inskinity
Stockholm, 111 28
Florakliniken
Stockholm, 113 28
The Faculty
Stockholm, 114 46
Svenska Hudkliniker
Stockholm
About this study
Official title: A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Voluma
A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region.
Read the detailed description
This will be a post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi- centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Voluma for the correction of midface volume deficit by tissue augmentation in cheek region.
Subjects desiring correction of cheek volume at the participating sites will be asked to participate in the clinical investigation. According to the national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.
If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 6 months with follow-up and assessments either by physical visits to a clinic (Visit 2 and Visit 4) or by phone call (Visit 3).
A total of 4 visits (including screening Visit 0) at the site are planned for each subject.
Standardized facial photography will be taken prior to and after treatment during Visit 1 and during each follow-up visit at the clinic (Visit 2 and 4), for evaluation according to GAIS grading and for the exploratory instrumental evaluation of cheek volume. GAIS will be used for blinded investigator assessment, treating investigator assessment and patient satisfaction.
Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2- optional touch up) will be used to measure pain.
- Conditions
- Midface Volume Deficit
- Being tested
- Decoria Voluma
- Keywords
- tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decoria VolumaDevice
Decoria® Voluma medical device is a sterile, single use Hyaloronic acid based dermal filler intended for aesthetic use, provided in the form of a nonpyrogenic, viscoelastic gel. It is composed of highly purified sodium hyaluronate of high molecular weight, dissolved in a physiological buffer at pH 6.0-7.5. The sodium hyaluronate is derived from microbial fermentation and is stabilized by crosslinking with the chemical agent BDDE (1,4 Butanediol Diglycidyl Ether).
Decoria® Voluma dermal fillers are injected into dermal tissue for the correction of midface volume deficit by tissue augmentation in cheek region, supporting overlying tissue to shape facial contours to desired level of correction. This is possible due to the capacity of HA to attract and bind large amounts of water, forming a viscous gel.
Appropriate injection volume for the cheek region(s) will be determined by the Treating investigator according to IFU.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Medical Device | Other | All eligable subjects desiring correction of cheek volume will receive intradermal injection of Decoria Voluma on either one or both sides of the face. Receives: Device: Decoria Voluma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
The primary efficacy endpoint is the blinded evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, which ranges from score 1 (exceptionally improved), 2 (much improved), 3 (improved), 4 (no change) to 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in cheek volume according to the GAIS grading. Each side of the face (left and right) will be assessed independently.
Measured: From pre-intervention baseline, to 6 months post-treatment
Primary safety endpoint
The primary safety endpoint is to assess the safety of Decoria® Voluma, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.
Measured: Baseline to end of study (6 months)
Secondary outcomes (5)
Secondary endpoint
- Pain will be measured by numerical scale Numeric Pain Rating Scale (NRS) (11-point verbal score completed for each target region treated) for each visit involving an injection.
Measured: Baseline (visit 1) and (visit 2) (30 days post baseline)
Secondary endpoint
- GAIS score at 1- and 6-months post-treatment, as assessed by the treating investigator.
Measured: 30 days and 180 days post treatment
Secondary endpoint
- GAIS score at 1- and 6-months post-treatment, as assessed by the subject.
Measured: 30 days and 180 days post treatment
Secondary endpoint
- Treatment-related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment.
Measured: Baseline (visit 1) and (visit 2) (30 days post baseline)
Secondary endpoint
- Change in cheek volume compared to baseline will be measured after treatment, as well as at
1- month and 6- months post-treatment visits.
Measured: Baseline, 30 days and 180 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start2 Sep 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midface Volume DeficitStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bohus Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Responsible party
- Sponsor
- Investigators
- Lucian Grema, M.D, Principal investigator, Florakliniken, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565988
- Sponsor's protocol ID
- CIV-24-03-046500
- Acronym
- DAG-VOL
- Status last verified
- Nov 2024
- First submitted
- 16 Aug 2024
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Voluma
- ClinicalTrials.gov ID
- NCT06565988
- Acronym / sponsor ID
- DAG-VOL / CIV-24-03-046500
- Conditions
- Midface Volume Deficit
- Keywords
- tissue augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Bohus Biotech ABIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 22 Aug 2024 (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.
A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region.
Detailed description
This will be a post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi- centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Voluma for the correction of midface volume deficit by tissue augmentation in cheek region.
Subjects desiring correction of cheek volume at the participating sites will be asked to participate in the clinical investigation. According to the national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.
If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 6 months with follow-up and assessments either by physical visits to a clinic (Visit 2 and Visit 4) or by phone call (Visit 3).
A total of 4 visits (including screening Visit 0) at the site are planned for each subject.
Standardized facial photography will be taken prior to and after treatment during Visit 1 and during each follow-up visit at the clinic (Visit 2 and 4), for evaluation according to GAIS grading and for the exploratory instrumental evaluation of cheek volume. GAIS will be used for blinded investigator assessment, treating investigator assessment and patient satisfaction.
Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2- optional touch up) will be used to measure pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Medical Device | Other | Device: Decoria VolumaAll eligable subjects desiring correction of cheek volume will receive intradermal injection of Decoria Voluma on either one or both sides of the face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years, males and females.
- Able and willing to give written informed consent for participation in the investigation.
- Treating investigator considers the subject's cheeks amenable to an improvement of at least 1 grade on the GAIS. At least one side of face should either have a potential to enhance cheek volume or have moderate to severe cheek volume deficit. The grades do not have to be the same on both sides.
- Ability to follow study instructions and likely to complete all required visits.
Key exclusion criteria (12 listed)
- Pregnant or lactating females.
- Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
- Any corrective procedures performed or planned in the midface region (e.g., silicone implants, permanent fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, dental implants) that may confound the evaluation of safety and performance of the IMD.
- Any other intradermal injection, such as semi-permanent fillers or botulinum toxin (no complications are allowed), received in the same injection area within 12 months of the Treatment visit (Visit 1) that may confound the evaluation of safety and performance of the IMD.
- Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
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 |
|---|---|---|
| Decoria VolumaDecoria® Voluma medical device is a sterile, single use Hyaloronic acid based dermal filler intended for aesthetic use, provided in the form of a nonpyrogenic, viscoelastic gel. It is composed of highly purified sodium hyaluronate of high molecular weight, dissolved in a physiological buffer at pH 6.0-7.5. The sodium hyaluronate is derived from microbial fermentation and is stabilized by crosslinking with the chemical agent BDDE (1,4 Butanediol Diglycidyl Ether). Decoria® Voluma dermal fillers are injected into dermal tissue for the correction of midface volume deficit by tissue augmentation in cheek region, supporting overlying tissue to shape facial contours to desired level of correction. This is possible due to the capacity of HA to attract and bind large amounts of water, forming a viscous gel. Appropriate injection volume for the cheek region(s) will be determined by the Treating investigator according to IFU. | Device | Investigational Medical Device |
Primary outcome
Primary efficacy endpoint
Time frame: From pre-intervention baseline, to 6 months post-treatment
The primary efficacy endpoint is the blinded evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, which ranges from score 1 (exceptionally improved), 2 (much improved), 3 (improved), 4 (no change) to 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in cheek volume according to the GAIS grading. Each side of the face (left and right) will be assessed independently.
Primary safety endpoint
Time frame: Baseline to end of study (6 months)
The primary safety endpoint is to assess the safety of Decoria® Voluma, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.
5 secondary outcomes
Secondary endpoint
Time frame: Baseline (visit 1) and (visit 2) (30 days post baseline)
Secondary endpoint
Time frame: 30 days and 180 days post treatment
Secondary endpoint
Time frame: 30 days and 180 days post treatment
Secondary endpoint
Time frame: Baseline (visit 1) and (visit 2) (30 days post baseline)
Secondary endpoint
Time frame: Baseline, 30 days and 180 days post treatment
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 27 Mar 2026.
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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.
Lucian Grema, M.D principal investigator
Florakliniken, Stockholm, Sweden
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decoria Voluma in people with Midface Volume Deficit, run by Bohus Biotech AB at 7 sites 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 4 inclusion and 12 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Primary efficacy endpoint (time frame: From pre-intervention baseline, to 6 months post-treatment). The study lists 2 primary outcomes in all. 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 27 Mar 2026.