NCT05808205

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

Recruiting now Last updated 24 April 2024

What this trial tests

trial testing • ALIAXIN EV: Essential Volume • ALIAXIN FL: Lips • ALIAXIN SR: Shape & Restore • ALIAXIN GP: Global Performance • ALIAXIN LV: Lips Volume in Esthetics in 350 participants. Currently enrolling.

Timeline

30 June 2021

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	Rose Pharma SA
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	350
Start date	30 June 2021
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across Italy

Drugs / interventions tested

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

Conditions studied

• Esthetics — all drugs for Esthetics →

Sponsor

Rose Pharma SA

Who can join

18 and older, any sex, with Esthetics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.