Status:
COMPLETED
Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss
Lead Sponsor:
Institute Hyalual GmbH
Conditions:
Aesthetic
Aesthetic Rejuvenation
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
This is a post-marketing, open-label, non-comparative, multi-center clinical investigation to evaluate the effectiveness and safety of the medical device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., ...
Detailed Description
This clinical investigation evaluated the effectiveness and safety of the CE-marked medical device "Alexa Volume," a cross-linked hyaluronic acid filler, for correction of midface volume loss in adult...
Eligibility Criteria
Inclusion
- Twenty-five (25) years of age or older at time of consent.
- Desire and willingness for correction or enhancement of his/her mid-face area.
- Subjects presenting with loss of volume and contour of the midface area 2 or more score according to MMVS bilaterally.
- Nasolabial folds severity grade 2 or more according to WSRS bilaterally.
- Treatment-naive subjects for fillers in the areas to be treated in the last 12 months, otherwise as decided by the Investigator.
- Subjects with signed informed consent and photo consent.
- Medical history and physical examination which, based on the Investigator's opinion, do not prevent the subject from taking part in the investigation and use the investigational medical device (IMD).
- Subjects not pregnant, non-breastfeeding.
- Subject must be willing to complete the entire course of the investigation.
Exclusion
- Pregnant, planning pregnancy during the investigation or breastfeeding women.
- Subjects with known hypersensitivity to any compound of the IMD.
- Subjects with history of any other adverse effect, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
- Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the injected area, including permanent fillers, that may interfere with the results.
- Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the investigation.
- Subjects with active inflammation or infection in the areas of Alexa administration.
- Subjects with tattoo and/or scar in the area of Alexa Volume administration that in the Investigator's opinion would interfere with investigation assessments.
- Subjects who tend to develop hypertrophic scarring.
- Subjects with impaired hemostatic function, which could prevent the subject from participating in the investigation according to the Investigator's opinion.
- Subjects with fibrosis, birthmark, or residual material in the area of intended use of Alexa Volume.
- Subjects participating in other clinical investigations within 30 days prior to the Visit 1.
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06984419
Start Date
June 29 2021
End Date
March 14 2022
Last Update
June 5 2025
Active Locations (4)
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1
Silmedic Sp. z o.o.
Katowice, Poland, 40-282
2
Provita Sp. z o.o.
Katowice, Poland, 40-611
3
Ośrodek Medyczny Osteomed s.c.
Krakow, Poland, 30-074
4
Institute Hyalual LLC
Kyiv, Ukraine, 03151