Evaluation of ALIAXIN Fillers for Facial Aesthetics

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

This study is testing how well and safely different ALIAXIN fillers can improve facial sagging, volume loss, and lip shape for people looking for aesthetic treatments.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rose Pharma SA (Industry-sponsored)
• Locations: 1 site (Milan)
• Trial ID: NCT05808205 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance and safety of various ALIAXIN fillers used for treating medium and deep facial sagging, volume defects, and lip contour issues. Patients will undergo a one-week screening phase followed by treatment with one or more ALIAXIN products based on clinical evaluation. The study will collect real-world evidence regarding the safety and effectiveness of these fillers in a clinical setting, focusing on patient-centered outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with medium to deep facial sagging or volume defects, including issues with lip volume and contours.

Not a fit: Patients with skin conditions affecting areas other than the face or those with sagging and volume defects in other body parts may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of ALIAXIN fillers' effectiveness and safety, leading to improved aesthetic outcomes for patients.

How similar studies have performed: While there are numerous studies on soft tissue fillers, this specific investigation focuses on ALIAXIN products, making it a novel approach in the context of post-marketing clinical follow-up.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Milan

• Clinica Capitanio - Istituto Auxologico Italiano IRCCS Milano — Milan, Italy (Recruiting)

Conditions Esthetics