Aesthetic Correction of the LipsDAG-ESSNCT07188818
Clinical Investigation on Lips Treated With HA-filler
A study testing Decoria Essence in people with Aesthetic Correction of the Lips, run by Bohus Biotech AB at 6 sites in Sweden.
Trial summary
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Correction of the Lips
- What is being tested?
- Decoria Essence
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesSweden
- Study dates
- 9 Dec 2024to Jul 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 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 lips amenable to an improvement of at least 1 grade on the GAIS. At least one lip should either have a potential to change (augmentation, contouring or both) or have moderate to severe volume deficit. The grades do not have to be the same on both lips.
- 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.
- 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.
- Subjects receiving interferon and ribavirin treatment.
- Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo below the nose.
- 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
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Advanced Clinic
Gothenburg, 41122
Svenska Hudkliniker Karlstad
Karlstad, 65225
Hansa Estetik
Malmö, 21138
Svenska Hudkliniker
Stockholm, 114 46
Dr Filip
Stockholm, 11456
Peri Estetik
Västerås, 72212
About this study
Official title: A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Essence
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Read the detailed description
A post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Subjects desiring correction and improvement of their lip 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 6 months with follow-up and assessments by visits in the clinic (Visit 2, Visit 3 and 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, Visit 4 and Visit 5). The photographs will be used for the evaluation of the primary efficacy endpoint of the blinded-evaluator using the Global Aesthetic Improvement Scale (GAIS) as well as the exploratory instrumental evaluation of the lip 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
- Aesthetic Correction of the Lips
- Being tested
- Decoria Essence
- Keywords
- lips profile, lip augmentation, correction of perioral rhytids, lip volume, lip contour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decoria EssenceDevice
Decoria® Essence is a hyaluronic acid based, BDDE-crosslinked dermal filler. Decoria® Essence dermal fillers are injected into dermal tissue to improve the volume and the contouring of the lips to desired level of correction by supporting the overlying tissue. Injection volume will be determined by the treating investigator according to the instructions for Use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Investigational Medical Device | Other | All eligible subjects desiring improvement and correction of their lip profile will receive injection of Decoria Essence in either one or both lips (upper, lower) and/or vermillion lines and/or perioral wrinkles/rhytids. Receives: Device: Decoria Essence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS)
The primary efficacy endpoint is to measure the change/improvement in score from pre-treatment baseline to 3 months post treatment by an independent evaluator, 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 (unaltered) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the lips according to the GAIS grading. Each lip (upper and lower) will be assessed independently.
Measured: From pre-intervention baseline (Visit 1, Day 0) to month 3 (Visit 3, Day 90).
Primary safety endpoint by evaluating Adverse Events
The primary safety endpoint is to assess the safety of Decoria® Essence, evaluated by the incidence, intensity, duration, and time of onset of related adverse events (AEs), including injection site reactions, collected during study duration.
Measured: From inclusion until the end of the study (6 months)
Secondary outcomes (6)
Secondary endpoint evaluating pain by Numeric Pain Rating Scale (NRS)
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. 0 representing "no pain" and 10 indicating the "worst pain imaginable"
Measured: At baseline (Visit 1, Day 0) and optional touch-up (Visit 2, Day 30)
Secondary endpoint evaluated improvement by GAIS score
GAIS (Global Aesthetic Improvement Scale) score at 1- months, 3 months and 6 months post-treatment, as assessed by the treating investigator and blinded evaluator. Scoring from 1-5 equals "very much improved," "much improved," "improved," "unchanged," and "worsened,"
Measured: At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)
Secondary endpoint by evaluating improvement by GAIS
GAIS (Global Aesthetic Improvement Scale) score at 1- month, 3- months and 6 months post-treatment, as assessed by the subject. Scoring from 1-5 equals "very much improved," "much improved," "improved," "unchanged," and "worsened,"
Measured: At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)
Secondary endpoint evaluating treatment related Adverse Events
Treatment related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment.
Measured: 30 days after injection of initial treatment (Day 0-30) and optional touch-up (Day 30-60)
Secondary endpoint by instrumental evaluation of lips by image analysis.
Change in lip compared to baseline will be measured after treatment, as well as at 1-month, 3-months and 6 months post-treatment visits. Instrumental evaluation of lips will be done by image analysis. A descriptive analysis of the semi.quantative change from baseline and after treatment will be done. Exploration of correction with other endpoints or measurements such as GAIS will be performed posthoc.
Measured: From pre-intervention baseline, to post-treatment at Day 1, 30, 90 and 180 respectively
Secondary endpoint evaluated outcome by GAIS score
GAIS (Global Aesthetic Improvement Scale) score at 1- months, 3 months and 6 months post-treatment, as assessed by the treating investigator and blinded evaluator. Scoring from 1-5 equals "very much improved," "much improved," "improved," "unchanged," and "worsened,"
Measured: At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start9 Dec 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetic Correction of the LipsStudies 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
- 100 participants (estimated)
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, Diagnostiskt Centrum Hud, Konsult LBG vard AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188818
- Sponsor's protocol ID
- CIV-24-04-046794
- Acronym
- DAG-ESS
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 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® Essence
- ClinicalTrials.gov ID
- NCT07188818
- Acronym / sponsor ID
- DAG-ESS / CIV-24-04-046794
- Conditions
- Aesthetic Correction of the Lips
- Keywords
- lips profile, lip augmentation, correction of perioral rhytids, lip volume, lip contour
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bohus Biotech ABIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Sep 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.
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Detailed description
A post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Subjects desiring correction and improvement of their lip 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 6 months with follow-up and assessments by visits in the clinic (Visit 2, Visit 3 and 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, Visit 4 and Visit 5). The photographs will be used for the evaluation of the primary efficacy endpoint of the blinded-evaluator using the Global Aesthetic Improvement Scale (GAIS) as well as the exploratory instrumental evaluation of the lip 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 EssenceAll eligible subjects desiring improvement and correction of their lip profile will receive injection of Decoria Essence in either one or both lips (upper, lower) and/or vermillion lines and/or perioral wrinkles/rhytids. |
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 lips amenable to an improvement of at least 1 grade on the GAIS. At least one lip should either have a potential to change (augmentation, contouring or both) or have moderate to severe volume deficit. The grades do not have to be the same on both lips.
- 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.
- 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 EssenceDecoria® Essence is a hyaluronic acid based, BDDE-crosslinked dermal filler. Decoria® Essence dermal fillers are injected into dermal tissue to improve the volume and the contouring of the lips to desired level of correction by supporting the overlying tissue. Injection volume will be determined by the treating investigator according to the instructions for Use (IFU). | Device | Investigational Medical Device |
Primary outcome
Primary efficacy endpoint to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS)
Time frame: From pre-intervention baseline (Visit 1, Day 0) to month 3 (Visit 3, Day 90).
The primary efficacy endpoint is to measure the change/improvement in score from pre-treatment baseline to 3 months post treatment by an independent evaluator, 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 (unaltered) and 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in the lips according to the GAIS grading. Each lip (upper and lower) will be assessed independently.
Primary safety endpoint by evaluating Adverse Events
Time frame: From inclusion until the end of the study (6 months)
The primary safety endpoint is to assess the safety of Decoria® Essence, evaluated by the incidence, intensity, duration, and time of onset of related adverse events (AEs), including injection site reactions, collected during study duration.
6 secondary outcomes
Secondary endpoint evaluating pain by Numeric Pain Rating Scale (NRS)
Time frame: At baseline (Visit 1, Day 0) and optional touch-up (Visit 2, Day 30)
Secondary endpoint evaluated improvement by GAIS score
Time frame: At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)
Secondary endpoint by evaluating improvement by GAIS
Time frame: At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)
Secondary endpoint evaluating treatment related Adverse Events
Time frame: 30 days after injection of initial treatment (Day 0-30) and optional touch-up (Day 30-60)
Secondary endpoint by instrumental evaluation of lips by image analysis.
Time frame: From pre-intervention baseline, to post-treatment at Day 1, 30, 90 and 180 respectively
Secondary endpoint evaluated outcome by GAIS score
Time frame: At Visit 1 (Day 0), Visit 2 (Day 30), Visit 3 (Day 90) and Visit 4 (Day 180)
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 27 Mar 2026.
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
Diagnostiskt Centrum Hud, Konsult LBG vard AB
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decoria Essence in people with Aesthetic Correction of the Lips, run by Bohus Biotech AB at 6 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: under way, not looking for participants, 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 6 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?
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?
Primary efficacy endpoint to measure the change/improvement in score using the Global Aesthetic Improvement Scale (GAIS) (time frame: From pre-intervention baseline (Visit 1, Day 0) to month 3 (Visit 3, Day 90).). 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.