Phase
Condition
N/ATreatment
Decoria Voluma
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ≥18 years, males and females.
Able and willing to give written informed consent for participation in theinvestigation.
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.
Ability to follow study instructions and likely to complete all required visits.
Exclusion
Exclusion Criteria:
Pregnant or lactating females.
Any previous hypersensitivity reaction to any constituent of the Investigationalmedical device (IMD) or to local anaesthetic products.
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.
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.
Has an ongoing episode/relapse, recently diagnosed or newly started medication of anautoimmune disease, as judged by the investigator.
Has any chronic or acute skin disease or inflammation (such as pimples, rashes orhives) within or close to the treatment area.
Has any treatments (thrombolytics, anticoagulants) or disease related to thecoagulation system.
Subjects that have taken any type of vaccine within two weeks prior injection withthe IMD.
Patients receiving interferon and ribavirin treatment.
Features that may interfere with the visual assessment such as recent cosmetictreatment,scarring, abscess, piercing or tattoo.
Participation in a clinical investigation that may affect the safety or performanceof this investigation, as judged by the Principal Investigator, or authorizeddesignee.
Employees of the study site or the sponsor directly involved with the conduct of theinvestigation.
Study Design
Study Description
Connect with a study center
Göteborgs Laser & Estetik
Gothenburg 2711537, 411 08
SwedenSite Not Available
Inskinity
Gothenburg 2711537, 411 07
SwedenActive - Recruiting
Göteborgs Laser & Estetik
Göteborg, 411 08
SwedenSite Not Available
Inskinity
Göteborg, 411 07
SwedenSite Not Available
Svenska Hudkliniker
Karlstad, 652 25
SwedenSite Not Available
Svenska Hudkliniker
Karlstad 2701680, 652 25
SwedenActive - Recruiting
Florakliniken
Stockholm, 113 28
SwedenActive - Recruiting
Inskinity
Stockholm, 111 28
SwedenSite Not Available
Svenska Hudkliniker
Stockholm,
SwedenActive - Recruiting
The Faculty
Stockholm, 114 46
SwedenActive - Recruiting
Florakliniken
Stockholm 2673730, 113 28
SwedenActive - Recruiting
Inskinity
Stockholm 2673730, 111 28
SwedenActive - Recruiting
Svenska Hudkliniker
Stockholm 2673730,
SwedenActive - Recruiting
The Faculty
Stockholm 2673730, 114 46
SwedenActive - Recruiting

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