RecruitingNCT05808205

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

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


Sponsor

Rose Pharma SA

Enrollment

350 participants

Start Date

Jun 30, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patient Informed consent form (ICF) signed;
  • M \& F Aged ≥ 18 years at the time of the signature of ICF;
  • Patients with medium and deep facial sagging, facial volume defects and/or lips volume and contours defects (nasolabial folds, wrinkles around the mouth facial and acne scars, glabellar wrinkles, wrinkles on the forehead, areas of the face which require enrichment of the facial tissue - cheeks, chin, cheekbones, lips - with temporary volumetric increase through growth of the soft tissues).
  • Willing to follow all study procedures, including attending all site visits, tests and examinations;
  • Willing to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions or laser) or intense cold after the treatment and until the complete absorption of swelling and reddening.

Exclusion Criteria17

  • Other - different - clinical conditions of skin layers;
  • Sagging and volume defects in other parts of the body different from face;
  • Infective or inflammatory processes near the area of intervention;
  • Presence of tendon, bone or muscular implants near the area of intervention;
  • Ongoing cutaneous allergies;
  • Serious and Chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy;
  • Known hypersensitivity to cheloids;
  • Allergy to device components;
  • Immune system illnesses;
  • Diabetes mellitus or uncontrolled systemic diseases;
  • Problems with coagulation or anti-coagulating therapies in progress;
  • Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAID, Vitamin E);
  • History of permanent filler treatment;
  • Known drug and/or alcohol abuse;
  • Mental incapacity that precludes adequate understanding or cooperation;
  • Participation in another investigational study;
  • Pregnancy Status (as per ALIAXIN products leaflet).

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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.


Locations(1)

Clinica Capitanio - Istituto Auxologico Italiano IRCCS Milano

Milan, Italy

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NCT05808205


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