Correction of Nasolabial FoldsDecorate01NCT05235126
A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF)
A study testing Decoria intense in people with Correction of Nasolabial Folds, run by Bohus Biotech AB at 2 sites in Sweden.
Trial summary
Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds
- What is being tested?
- Decoria intense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesSweden
- Study dates
- 17 Feb 2022to 3 Mar 2023
- 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
- Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
- The subject has nasolabial folds considered at least moderate (grade 3) according to the Wrinkle Severity Rating Scale (WSRS), as assessed by the Principal Investigator.
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 acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
- Any bleeding disorder or treatment with thrombolytics or anticoagulants.
- Any treatment with interferon and ribavirin.
- Any vaccine taken within 2 weeks prior to the treatment visit.
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- Any other intradermal injection, such as fillers or toxins, received in the same injection area within 6 months of the Screening and Treatment visit (Visit 1).
- Participation in a clinical investigation study that may affect the safety or performance of this investigation, within one year of enrolment, or planned participation in such investigation at any time during this clinical investigation, as judged by the Principal Investigator.
- Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator.
- Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Post-market, Prospective, Observational (Non-interventional), Partly Confirmatory, Multi-centre Clinical Investigation to Confirm the Clinical Safety and Performance Profile of Decoria® Intense Hyaluronic Acid Dermal Filler for the Correction of Nasolabial Folds.
Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds.
According to the new MDR in EU this clinical investigation will confirm efficacy and safety of Decoria intense.
Read more
The plan is to recruit 80 subjects to receive 64 evaluable subjects during 6 months recruitment.
The clinical investigation contains 5 visits and the total time per subject is 12 months. All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS)
- Conditions
- Correction of Nasolabial Folds
- Being tested
- Decoria intense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decoria intenseDevice
All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS).
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Other | All subjects receive treatment at V1 and option to receive touch-up at V2. Receives: Device: Decoria intense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the WSRS score
The primary efficacy endpoint is to measure the change in the WSRS score from pre-treatment baseline, at 3 months post OCR, as assessed by the Principal Investigator. The WSRS range from 1 (absent - no visible fold) to 5 (extreme - extremely deep and long folds). A subject improving 1 score or more is classified as "responder". A stable subject or a subject worsening is classified as "non-responder".
Measured: 3 months after pre-treatment (baseline)
The rate of adverse events
The primary safety endpoint is to assess the safety of Decoria® intense, evaluated by the rate of adverse events throughout the study period.
Measured: 12 months.
Secondary outcomes (2)
Subject satisfaction with treatment
The subject will assess the satisfaction with the treatment at all visits using the Global Aesthetic Improvement Scale (GAIS) 1 - 5. 1. Exceptional improvement, 2. Very improved patient, 3. Improved patient, 4. Unaltered patient, 5. Worsened patient.
Measured: 12 months
PI satisfaction with treatment
The PI will assess the satisfaction with the treatment at all visits except for visit 5 (telephone visit) using the Global Aesthetic Improvement Scale (GAIS) 1 - 5. 1. Exceptional improvement, 2. Very improved patient, 3. Improved patient, 4. Unaltered patient, 5. Worsened patient.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start17 Feb 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correction of Nasolabial FoldsStudies 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
- All subjects will receive open treatment with Decoria intense for correction of nasolabial folds at Visit 1 with optional touch-up at Visit 2.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bohus Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucian Grema, MD, Principal investigator, Florakliniken Stockholm Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235126
- Sponsor's protocol ID
- Decorate01
- Acronym
- Decorate01
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2022
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Prospective, Observational (Non-interventional), Partly Confirmatory, Multi-centre Clinical Investigation to Confirm the Clinical Safety and Performance Profile of Decoria® Intense Hyaluronic Acid Dermal Filler for the Correction of Nasolabial Folds.
- ClinicalTrials.gov ID
- NCT05235126
- Acronym / sponsor ID
- Decorate01 / Decorate01
- Conditions
- Correction of Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bohus Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 11 Feb 2022 (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.
Decoria intense is a class III medical device and is CE-marked and has been on the market since 2014. Decoria intense is a hyaluronic acid filler that will be used according to intended use for correction of nasolabial folds.
According to the new MDR in EU this clinical investigation will confirm efficacy and safety of Decoria intense.
The plan is to recruit 80 subjects to receive 64 evaluable subjects during 6 months recruitment.
The clinical investigation contains 5 visits and the total time per subject is 12 months. All subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive open treatment with Decoria intense for correction of nasolabial folds at Visit 1 with optional touch-up at Visit 2.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Other | Device: Decoria intenseAll subjects receive treatment at V1 and option to receive touch-up at V2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
- The subject has nasolabial folds considered at least moderate (grade 3) according to the Wrinkle Severity Rating Scale (WSRS), as assessed by the Principal Investigator.
Key exclusion criteria (10 listed)
- Pregnant or lactating females.
- Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
- Any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
- Any bleeding disorder or treatment with thrombolytics or anticoagulants.
- Any treatment with interferon and ribavirin.
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 intenseAll subjects will receive treatment at Visit 1 with the option to receive a touch-up treatment at Visit 2. Evaluation of the nasolabial folds will be performed by PI using the Wrinkle Severity Rating Scale (WSRS). | Device | Treatment arm |
Primary outcome
Change in the WSRS score
Time frame: 3 months after pre-treatment (baseline)
The primary efficacy endpoint is to measure the change in the WSRS score from pre-treatment baseline, at 3 months post OCR, as assessed by the Principal Investigator. The WSRS range from 1 (absent - no visible fold) to 5 (extreme - extremely deep and long folds). A subject improving 1 score or more is classified as "responder". A stable subject or a subject worsening is classified as "non-responder".
The rate of adverse events
Time frame: 12 months.
The primary safety endpoint is to assess the safety of Decoria® intense, evaluated by the rate of adverse events throughout the study period.
2 secondary outcomes
Subject satisfaction with treatment
Time frame: 12 months
PI satisfaction with treatment
Time frame: 6 months
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.
- 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.
Lucian Grema, MD principal investigator
Florakliniken Stockholm Sweden
2 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 in people with Correction of Nasolabial Folds, run by Bohus Biotech AB at 2 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 3 inclusion and 10 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 2 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?
Change in the WSRS score (time frame: 3 months after pre-treatment (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.