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

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

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.

Study Overview

• Status: Completed
• Conditions: Midface Volume Deficit
• Intervention / Treatment: Device: Decoria Voluma

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 411 07
    • Inskinity
  • Gothenburg, Sweden, 411 08
    • Göteborgs Laser & Estetik
  • Karlstad, Sweden, 652 25
    • Svenska Hudkliniker
  • Stockholm, Sweden, 111 28
    • Inskinity
  • Stockholm, Sweden, 113 28
    • Florakliniken
  • Stockholm, Sweden, 114 46
    • The Faculty
  • Stockholm, Sweden
    • Svenska Hudkliniker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Investigational Medical Device; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoint	1. Pain will be measured by numerical scale Numeric Pain Rating Scale (NRS) (11-point verbal score completed for each target region treated) for each visit involving an injection.	Baseline (visit 1) and (visit 2) (30 days post baseline)
Secondary endpoint	2. GAIS score at 1- and 6-months post-treatment, as assessed by the treating investigator.	30 days and 180 days post treatment
Secondary endpoint	3. GAIS score at 1- and 6-months post-treatment, as assessed by the subject.	30 days and 180 days post treatment
Secondary endpoint	4. Treatment-related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment.	Baseline (visit 1) and (visit 2) (30 days post baseline)
Secondary endpoint	5. Change in cheek volume compared to baseline will be measured after treatment, as well as at 1- month and 6- months post-treatment visits.	Baseline, 30 days and 180 days post treatment

Collaborators and Investigators

• Sponsor: Bohus Biotech AB
• Collaborators: Key2Compliance
• Investigators: Principal Investigator: Lucian Grema, M.D, Florakliniken, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): September 26, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: tissue augmentation
• Other Study ID Numbers: CIV-24-03-046500

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No