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

Last updated: September 19, 2025
Sponsor: Bohus Biotech AB
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Decoria Voluma

Clinical Study ID

NCT06565988
CIV-24-03-046500
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥18 years, males and females.

  2. Able and willing to give written informed consent for participation in theinvestigation.

  3. Treating investigator considers the subject's cheeks amenable to an improvement ofat least 1 grade on the GAIS. At least one side of face should either have apotential 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

Exclusion Criteria:

  1. Pregnant or lactating females.

  2. Any previous hypersensitivity reaction to any constituent of the Investigationalmedical device (IMD) or to local anaesthetic products.

  3. Any corrective procedures performed or planned in the midface region (e.g., siliconeimplants, permanent fillers, absorbable and non-absorbable sutures, laser therapy,dermabrasion, dental implants) that may confound the evaluation of safety andperformance 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 monthsof the Treatment visit (Visit 1) that may confound the evaluation of safety andperformance of the IMD.

  5. Has an ongoing episode/relapse, recently diagnosed or newly started medication of anautoimmune disease, as judged by the investigator.

  6. Has any chronic or acute skin disease or inflammation (such as pimples, rashes orhives) within or close to the treatment area.

  7. Has any treatments (thrombolytics, anticoagulants) or disease related to thecoagulation system.

  8. Subjects that have taken any type of vaccine within two weeks prior injection withthe IMD.

  9. Patients receiving interferon and ribavirin treatment.

  10. Features that may interfere with the visual assessment such as recent cosmetictreatment,scarring, abscess, piercing or tattoo.

  11. Participation in a clinical investigation that may affect the safety or performanceof this investigation, as judged by the Principal Investigator, or authorizeddesignee.

  12. Employees of the study site or the sponsor directly involved with the conduct of theinvestigation.

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Decoria Voluma
Phase:
Study Start date:
September 02, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Göteborgs Laser & Estetik

    Gothenburg 2711537, 411 08
    Sweden

    Site Not Available

  • Inskinity

    Gothenburg 2711537, 411 07
    Sweden

    Active - Recruiting

  • Göteborgs Laser & Estetik

    Göteborg, 411 08
    Sweden

    Site Not Available

  • Inskinity

    Göteborg, 411 07
    Sweden

    Site Not Available

  • Svenska Hudkliniker

    Karlstad, 652 25
    Sweden

    Site Not Available

  • Svenska Hudkliniker

    Karlstad 2701680, 652 25
    Sweden

    Active - Recruiting

  • Florakliniken

    Stockholm, 113 28
    Sweden

    Active - Recruiting

  • Inskinity

    Stockholm, 111 28
    Sweden

    Site Not Available

  • Svenska Hudkliniker

    Stockholm,
    Sweden

    Active - Recruiting

  • The Faculty

    Stockholm, 114 46
    Sweden

    Active - Recruiting

  • Florakliniken

    Stockholm 2673730, 113 28
    Sweden

    Active - Recruiting

  • Inskinity

    Stockholm 2673730, 111 28
    Sweden

    Active - Recruiting

  • Svenska Hudkliniker

    Stockholm 2673730,
    Sweden

    Active - Recruiting

  • The Faculty

    Stockholm 2673730, 114 46
    Sweden

    Active - Recruiting

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