NCT06565988

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Bohus Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 Decoria® Voluma for the correction of midface volume deficit by tissue augmentation in cheek region. Subjects desiring correction of cheek volume at the participating sites will be asked to participate in the clinical investigation. According to the national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time. If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 6 months with follow-up and assessments either by physical visits to a clinic (Visit 2 and Visit 4) or by phone call (Visit 3). A total of 4 visits (including screening Visit 0) at the site are planned for each subject. Standardized facial photography will be taken prior to and after treatment during Visit 1 and during each follow-up visit at the clinic (Visit 2 and 4), for evaluation according to GAIS grading and for the exploratory instrumental evaluation of cheek volume. GAIS will be used for blinded investigator assessment, treating investigator assessment and patient satisfaction. Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2- optional touch up) will be used to measure pain.

Conditions

• Midface Volume Deficit

Interventions

Type	Name	Description
DEVICE	Decoria Voluma	Decoria® Voluma medical device is a sterile, single use Hyaloronic acid based dermal filler intended for aesthetic use, provided in the form of a nonpyrogenic, viscoelastic gel. It is composed of highly purified sodium hyaluronate of high molecular weight, dissolved in a physiological buffer at pH 6.0-7.5. The sodium hyaluronate is derived from microbial fermentation and is stabilized by crosslinking with the chemical agent BDDE (1,4 Butanediol Diglycidyl Ether). Decoria® Voluma dermal fillers are injected into dermal tissue for the correction of midface volume deficit by tissue augmentation in cheek region, supporting overlying tissue to shape facial contours to desired level of correction. This is possible due to the capacity of HA to attract and bind large amounts of water, forming a viscous gel. Appropriate injection volume for the cheek region(s) will be determined by the Treating investigator according to IFU.

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-09-26
• Completion: 2025-09-26
• First posted: 2024-08-22
• Last updated: 2026-03-27

Locations

7 sites across 1 country: Sweden