Investigation of Decoria® Voluma for cheek volume enhancement

A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria® Voluma

This study is testing whether Decoria® Voluma can safely improve cheek volume for people who feel their cheeks lack fullness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bohus Biotech AB (Industry-sponsored)
• Locations: 7 sites (Göteborg and 6 other locations)
• Trial ID: NCT06565988 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the safety and performance of Decoria® Voluma in correcting midface volume deficits through tissue augmentation in the cheek region. It is a post-market, open-label, prospective, interventional study that involves multiple centers and includes evaluator-blinded assessments. Participants will receive treatment and undergo follow-up assessments over a period of six months, with standardized facial photography taken to evaluate outcomes. The study will assess both patient satisfaction and clinical effectiveness using the GAIS grading system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe cheek volume deficits who are seeking aesthetic improvement.

Not a fit: Patients who are pregnant, lactating, or have a history of hypersensitivity to the treatment components will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide patients with a safe and effective option for enhancing cheek volume and improving facial aesthetics.

How similar studies have performed: Other studies involving tissue augmentation for facial volume enhancement have shown positive outcomes, indicating that this approach is supported by prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥18 years, males and females.
2. Able and willing to give written informed consent for participation in the investigation.
3. 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.
4. Ability to follow study instructions and likely to complete all required visits.

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 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.
4. 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.
5. Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator.
6. Has any chronic or acute skin disease or inflammation (such as pimples, rashes or hives) within or close to the treatment area.
7. Has any treatments (thrombolytics, anticoagulants) or disease related to the coagulation system.
8. Subjects that have taken any type of vaccine within two weeks prior injection with the IMD.
9. Patients receiving interferon and ribavirin treatment.
10. Features that may interfere with the visual assessment such as recent cosmetic treatment,scarring, abscess, piercing or tattoo.
11. Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee.
12. Employees of the study site or the sponsor directly involved with the conduct of the investigation.

Where this trial is running

Göteborg and 6 other locations

• Inskinity — Göteborg, Sweden (Recruiting)
• Göteborgs Laser & Estetik — Göteborg, Sweden (Not_yet_recruiting)
• Svenska Hudkliniker — Karlstad, Sweden (Recruiting)
• Inskinity — Stockholm, Sweden (Recruiting)
• Florakliniken — Stockholm, Sweden (Recruiting)
• The Faculty — Stockholm, Sweden (Recruiting)
• Svenska Hudkliniker — Stockholm, Sweden (Recruiting)

Study contacts

• Principal investigator: Lucian Grema, M.D — Florakliniken, Stockholm, Sweden
• Study coordinator: Michelle Johansson

Conditions Midface Volume Deficit; tissue augmentation