CompletedNot Applicable

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

Sweden111 participantsStarted 2024-09-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Primary efficacy endpoint

Timeframe: From pre-intervention baseline, to 6 months post-treatment

Primary safety endpoint

Timeframe: Baseline to end of study (6 months)

Trial details

NCT IDNCT06565988

SponsorBohus Biotech AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-26

View on ClinicalTrials.gov More Midface Volume Deficit trials