Status:
ENROLLING_BY_INVITATION
Clinical Investigation on Lips Treated With HA-filler
Lead Sponsor:
Bohus Biotech AB
Collaborating Sponsors:
Key2Compliance
Conditions:
Aesthetic Correction of the Lips
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
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® Essen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07188818
Start Date
December 9 2024
End Date
July 1 2026
Last Update
October 2 2025
Active Locations (6)
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1
Advanced Clinic
Gothenburg, Sweden, 41122
2
Svenska Hudkliniker Karlstad
Karlstad, Sweden, 65225
3
Hansa Estetik
Malmo, Sweden, 21138
4
Svenska Hudkliniker
Stockholm, Sweden, 114 46