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

NCT06565988 | Completed

• 1 other identifier: CIV-24-03-046500
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 7

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.

Conditions

Midface Volume Deficit

Keywords

tissue augmentation

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint

  The primary efficacy endpoint is the blinded evaluator assessment of improvement using the Global Aesthetic Improvement Scale (GAIS). GAIS is a comparative scale, based on assessment of change since before pre-intervention, which ranges from score 1 (exceptionally improved), 2 (much improved), 3 (improved), 4 (no change) to 5 (worse). The blinded evaluator will compare the pre-intervention face to post-intervention face and assign the level of improvement in cheek volume according to the GAIS grading. Each side of the face (left and right) will be assessed independently.

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

• Primary safety endpoint

  The primary safety endpoint is to assess the safety of Decoria® Voluma, evaluated by the incidence, intensity, duration, and time of onset of related AEs, including injection site reactions, collected during the study duration.

  Baseline to end of study (6 months)

Secondary Outcomes (5)

• Secondary endpoint

  Baseline (visit 1) and (visit 2) (30 days post baseline)

• Secondary endpoint

  30 days and 180 days post treatment

• Secondary endpoint

  30 days and 180 days post treatment

• Secondary endpoint

  Baseline (visit 1) and (visit 2) (30 days post baseline)

• Secondary endpoint

  Baseline, 30 days and 180 days post treatment

Study Arms (1)

Investigational Medical Device

OTHER

All eligable subjects desiring correction of cheek volume will receive intradermal injection of Decoria Voluma on either one or both sides of the face.

Device: Decoria Voluma

Interventions

Decoria Voluma DEVICE

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.

Investigational Medical Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bohus Biotech AB: lead
• Key2Compliance: collaborator

Study Sites (7)

Inskinity

Gothenburg, 411 07, Sweden

Location

Göteborgs Laser & Estetik

Gothenburg, 411 08, Sweden

Location

Svenska Hudkliniker

Karlstad, 652 25, Sweden

Location

Inskinity

Stockholm, 111 28, Sweden

Location

Florakliniken

Stockholm, 113 28, Sweden

Location

The Faculty

Stockholm, 114 46, Sweden

Location

Svenska Hudkliniker

Stockholm, Sweden

Location

Study Officials

• Lucian Grema, M.D

  Florakliniken, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 22, 2024
• Study Start: September 2, 2024
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: March 27, 2026

Record last verified: 2024-11

Locations

SE (7)