Jawline Contour DeficitDAG-ISJNCT06562075
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense Strong
A study testing Decoria Intense Strong in people with Jawline Contour Deficit, run by Bohus Biotech AB at 7 sites in Sweden.
Trial summary
A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jawline Contour Deficit
- What is being tested?
- Decoria Intense Strong
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 7 sitesSweden
- Study dates
- 6 Sep 2024to 25 Dec 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 jaw (including or not including chin) amenable to an improvement of at least 1 grade on GAIS. At least one side with either potential to enhance contouring or moderate to severe loss of jawline definition. 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 anesthetic products.
- Performed or planned surgery below the nose, permanent implant, injection with fat, and deoxycholic acid that may confound the evaluation of safety and performance of the IMD.
- Any other intradermal injection, such as semi-permanent fillers or botulinum toxins (no complications are allowed), received in the same injection area within 9 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 etc) 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
Göteborg 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
A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.
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®Intense Strong for the correction and improvement of jawline profile.
Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation. According to 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 9 months with follow-up and assessments by visits (Visit 2, Visit 3 and Visit 5) and phone call (Visit 4).
Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3 and Visit 5), for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour. GAIS will be used for blinded-evaluator 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
- Jawline Contour Deficit
- Being tested
- Decoria Intense Strong
- Keywords
- jawline profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decoria Intense StrongDevice
Decoria® Intense Strong is a HA-based, BDDE-crosslinked dermal filler. Decoria® Intense Strong dermal fillers are injected into dermal tissue to improve and define contouring of jawline profile, supporting overlying tissue to shape facial contours to desired level of correction.
Appropriate injection volume for the jawline 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 their jawline profile will receive intradermal injection of Decoria Intense Strong on either one or both sides of the face (including or not including the chin). Receives: Device: Decoria Intense Strong |
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, ranges from 1 (exceptional improvement) to 4 (no change) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the jawline according to the GAIS grading. Each side (left and right) will be assessed independently.
Measured: From pre-intervention baseline, at Visit 3 (3 months post baseline).
Primary safety endpoint
The primary safety endpoint is to assess the safety of Decoria® Intense Strong, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.
Measured: From baseline to end of study (9 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: From baseline to visit 2 (1 month optional touch-up)
Secondary endpoint
- GAIS score at 3 months, and 9 months post-treatment, as assessed by the treating investigator.
Measured: 90 days respectively 270 days after IMD injection
Secondary endpoint
- GAIS score at 3 months, and 9 months post-treatment, as assessed by the subject.
Measured: 90 days respectively 270 days after IMD injection
Secondary endpoint
- Treatment related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment.
Measured: 30 days between visit 1 and visit 2
Secondary endpoint
- Change in jawline contour compared to baseline will be measured after treatment, as well as at 1-month, 3-months, and 9-months post-treatment visits.
Measured: 30 days, 90 days and 270 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 posted20 Aug 2024
- Study start6 Sep 2024
- Primary completion12 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jawline Contour 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
- 114 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
- NCT06562075
- Sponsor's protocol ID
- CIV-24-03-046499
- Acronym
- DAG-ISJ
- Status last verified
- Jan 2026
- 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 by Decoria® Intense Strong
- ClinicalTrials.gov ID
- NCT06562075
- Acronym / sponsor ID
- DAG-ISJ / CIV-24-03-046499
- Conditions
- Jawline Contour Deficit
- Keywords
- jawline profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bohus Biotech ABIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 20 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 Follow up clinical investigation to confirm the clinical safety and performance profile of Decoria®Intense Strong for the correction and improvement of jawline profile.
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®Intense Strong for the correction and improvement of jawline profile.
Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation. According to 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 9 months with follow-up and assessments by visits (Visit 2, Visit 3 and Visit 5) and phone call (Visit 4).
Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3 and Visit 5), for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour. GAIS will be used for blinded-evaluator 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 Intense StrongAll eligable subjects desiring correction of their jawline profile will receive intradermal injection of Decoria Intense Strong on either one or both sides of the face (including or not including the chin). |
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 jaw (including or not including chin) amenable to an improvement of at least 1 grade on GAIS. At least one side with either potential to enhance contouring or moderate to severe loss of jawline definition. 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 anesthetic products.
- Performed or planned surgery below the nose, permanent implant, injection with fat, and deoxycholic acid that may confound the evaluation of safety and performance of the IMD.
- Any other intradermal injection, such as semi-permanent fillers or botulinum toxins (no complications are allowed), received in the same injection area within 9 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 Intense StrongDecoria® Intense Strong is a HA-based, BDDE-crosslinked dermal filler. Decoria® Intense Strong dermal fillers are injected into dermal tissue to improve and define contouring of jawline profile, supporting overlying tissue to shape facial contours to desired level of correction. Appropriate injection volume for the jawline 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, at Visit 3 (3 months post baseline).
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, ranges from 1 (exceptional improvement) to 4 (no change) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the jawline according to the GAIS grading. Each side (left and right) will be assessed independently.
Primary safety endpoint
Time frame: From baseline to end of study (9 months)
The primary safety endpoint is to assess the safety of Decoria® Intense Strong, 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: From baseline to visit 2 (1 month optional touch-up)
Secondary endpoint
Time frame: 90 days respectively 270 days after IMD injection
Secondary endpoint
Time frame: 90 days respectively 270 days after IMD injection
Secondary endpoint
Time frame: 30 days between visit 1 and visit 2
Secondary endpoint
Time frame: 30 days, 90 days and 270 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.
Related trials for Jawline Contour Deficit
RecruitingPhase 4
Evaluation of Filler Injection for Chin Profile Enhancement
Chin Regression, Chin Asymmetry
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
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 Intense Strong in people with Jawline Contour 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, at Visit 3 (3 months post baseline).). 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.