Status:
RECRUITING
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Voluma
Lead Sponsor:
Bohus Biotech AB
Collaborating Sponsors:
Key2Compliance
Conditions:
Midface Volume Deficit
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A post-market-clinical follow-up investigation of safety and performance of Decoria® Voluma by the correction of midface volume deficit by tissue augmentation in cheek region.
Detailed Description
This will be a post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi- centre, clinical investigation to confirm the clinical safety and performance profile of De...
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 cheeks amenable to an improvement of at least 1 grade on the GAIS. At least one side of face should either have a potential to enhance cheek volume or have moderate to severe cheek volume deficit. The grades do not have to be the same on both sides.
- 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.
- Any corrective procedures performed or planned in the midface region (e.g., silicone implants, permanent fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, dental implants) that may confound the evaluation of safety and performance of the IMD.
- Any other intradermal injection, such as semi-permanent fillers or botulinum toxin (no complications are allowed), received in the same injection area within 12 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) or disease related to the coagulation system.
- Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
- Patients receiving interferon and ribavirin treatment.
- Features that may interfere with the visual assessment such as recent cosmetic treatment,scarring, abscess, piercing or tattoo.
- 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 :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06565988
Start Date
September 2 2024
End Date
September 1 2025
Last Update
September 22 2025
Active Locations (7)
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1
Inskinity
Gothenburg, Sweden, 411 07
2
Göteborgs Laser & Estetik
Gothenburg, Sweden, 411 08
3
Svenska Hudkliniker
Karlstad, Sweden, 652 25
4
Inskinity
Stockholm, Sweden, 111 28