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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
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.
Inskinity
Gothenburg, Sweden
RECRUITINGGöteborgs Laser & Estetik
Gothenburg, Sweden
NOT_YET_RECRUITINGSvenska Hudkliniker
Karlstad, Sweden
RECRUITINGPrimary 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.
Time frame: 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.
Time frame: Baseline to end of study (6 months)
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.
Time frame: 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.
Time frame: 30 days and 180 days post treatment
Secondary endpoint
3\. GAIS score at 1- and 6-months post-treatment, as assessed by the subject.
Time frame: 30 days and 180 days post treatment
Secondary endpoint
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Inskinity
Stockholm, Sweden
RECRUITINGFlorakliniken
Stockholm, Sweden
RECRUITINGThe Faculty
Stockholm, Sweden
RECRUITINGSvenska Hudkliniker
Stockholm, Sweden
RECRUITING4\. Treatment-related adverse events and injection site reactions reported after touch-up should be similar to those reported after initial treatment.
Time frame: 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.
Time frame: Baseline, 30 days and 180 days post treatment