Clinical trial NCT05235126: A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Correction of Nasolabial Folds
Lead sponsor: Bohus Biotech AB
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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.

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)


Eligibility criteria: Inclusion Criteria:

1. Male or Female, ≥18 years of age, of all weight spans, desiring correction of their nasolabial folds.
2. 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).
3. 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.

Exclusion Criteria:

1. Pregnant or lactating females.
2. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products.
3. Any acute or chronic skin disease or inflammation (such as pimples, rashes or hives) within or close to the area selected for correction.
4. Any bleeding disorder or treatment with thrombolytics or anticoagulants.
5. Any treatment with interferon and ribavirin.
6. Any vaccine taken within 2 weeks prior to the treatment visit.
7. 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).
8. 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.
9. Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator.
10. Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.

Primary outcomes:
measure: Change in the WSRS score
timeFrame: 3 months after pre-treatment (baseline)
measure: The rate of adverse events
timeFrame: 12 months.
Secondary outcomes:
measure: Subject satisfaction with treatment
timeFrame: 12 months
measure: PI satisfaction with treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: MyBeauty Clinic
city: Stockholm
country: Sweden
facility: Florakliniken
Study officials:
affiliation: Florakliniken Stockholm Sweden
name: Lucian Grema, MD
role: PRINCIPAL_INVESTIGATOR
References: