MedTrace Logo

An Open, Non-comparative, Single-centre Post Marketing Clinical Followup (PMCF) Investigation to Evaluate Performance and Safety of the ALIAXIN Fillers Used as Intended

NCT05808205 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2024-04-24

No results posted yet for this study

Summary

This is an open, non-comparative, Single-centre Post Marketing Clinical Followup (PMCF) study aimed to enrol patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects. The investigation will be useful to collect Investigational Product' real world safety /performance evidences in normal clinical practice. Each subject, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted. At baseline visit (Visit 0), as per clinical practice, the subject can be treated with one or more of the below ALIAXIN products, depending on investigator clinical evaluation and decision:

* ALIAXIN EV: Essential Volume
* ALIAXIN FL: Lips
* ALIAXIN SR: Shape \& Restore
* ALIAXIN GP: Global Performance
* ALIAXIN LV: Lips Volume According the investigator judgment and IP' Instruction For Use (IFU), each subject can be treated in one or more of following face area:
* Temporal / frontal area
* Orbital / Malar area
* Perioral area
* Lips. For the pre- and post-treatment clinical evaluations, a LifeViz® Mini 3D camera (QuantifiCare) will be used for face-images capture. A LifeViz® Micro 3D camera (QuantifiCare) will be used for adjuvant images capture, only in specific conditions (e.g. nasolabial folds and marionette lines) and according to the Principal Investigator judgment, to facilitate the clinical evaluation. As per clinical practice, the treatment can be repeated at touch up visit (Visit 1), after 15 days from Visit 0, according the investigator clinical evaluation and decision, to maintain/refine the obtained results. Moreover, after 6 months from Visit 0, as per clinical practice, a visit ( Visit 2, End of Study Visit) will be performed to collect and evaluate the safety and performance of treatment(s) performed. Considering the normal clinical practice, after Visit 2, according the investigator judgment and after a new Informed Consent Form signature, the subject can be enrolled in a new screening phase as per clinical study design. The re-enrolled subject should meet all inclusion and none exclusion criteria. In the new CRF will be reported the previous subject's identification number.

Conditions

  • Esthetics

Interventions

DEVICE

• ALIAXIN EV: Essential Volume • ALIAXIN FL: Lips • ALIAXIN SR: Shape & Restore • ALIAXIN GP: Global Performance • ALIAXIN LV: Lips Volume

According the investigator judgment and IP' Instruction For Use (IFU), each subject can be treated in one or more of following face area: * Temporal / frontal area * Orbital / Malar area * Perioral area * Lips.

Sponsors & Collaborators

  • Rose Pharma SA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808205 on ClinicalTrials.gov