Status:
COMPLETED
A Clinical Investigation of the Decoria® Aesthetic Group (DAG) for Correction of Nasolabial Folds (NLF)
Lead Sponsor:
Bohus Biotech AB
Conditions:
Correction of Nasolabial Folds
Eligibility:
All Genders
18+ years
Phase:
NA
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 correc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05235126
Start Date
February 17 2022
End Date
March 3 2023
Last Update
September 22 2025
Active Locations (2)
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1
MyBeauty Clinic
Halmstad, Sweden, 302 32
2
Florakliniken
Stockholm, Sweden