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 | Recruiting

• 1 other identifier: RP-ALX-01_2019
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To evaluate the re-volumizing performance of the filler ALIAXIN during all study duration compared to baseline volume. Change will be assessed.

  To evaluate the re-volumizing performance of the filler ALIAXIN (Essential Volume (EV), Lips (FL), Shape \& Restore (SR), Global Performance (GP) and Lips Volume (LV)) used as Intended in patients with facial volume defects, by treated areas calculating the volume variation (expressed as cm3) during all study duration compared to baseline volume. A 3D camera will be used to take subject' face images at all planned visits.

  V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0). Change will be assessed.

Secondary Outcomes (3)

• To evaluate the corrective performance of the ALIAXIN fillers during all study duration by Global Aesthetic Improvement Scale (GAIS).

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) and V2 (6 months from V0).

• To evaluate the re-volumizing performance of each Filler ALIAXIN during all study duration compared to baseline volume. Change will be assessed.

  V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0). Change will be assessed.

• To evaluate the tolerability and patient satisfaction of the filler ALIAXIN during all study duration.

  V0 (Baseline visit day 0, IP administration) V1 (15 days from V0) and V2 (6 months from V0).

Other Outcomes (4)

• Safety will be monitored through vital signs by Blood Pressure

  V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0)

• Safety will be monitored through vital signs by Heart Rate

  V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0)

• Safety will be monitored through facial examination. PI will observe the presence of erythema and hematomas

  V-1(Week -1 Screening visit), V0 (Baseline visit day 0, IP administration). V-1 and V0 may coincide. V1 (15 days from V0) and V2 (6 months from V0)

Study Arms (1)

Open Non-comparative

In this study, it is planned to include about 70 patients each year, assuming two treatments per patient. Due to the post-market nature of the study, this sample size is not based on a formal statistical sample size calculation, but the size is considered appropriate for the study purposes and considering the enrollment rate estimated at the center.

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

Interventions

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

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.

Open Non-comparative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study, it is planned to include about 70 patients each year, assuming two treatments per patient. Due to the post-market nature of the study, this sample size is not based on a formal statistical sample size calculation, but the size is considered appropriate for the study purposes and considering the enrollment rate estimated at the center. To ensure the evaluation of all defined areas, for each 6 months follow-up period, it is intended that the investigational site will perform a minimum of 5 evaluations for every identified facial area (i.e., Temporal / frontal area, Orbital / Malar area, Perioral area, Lips). Considering that each subject can be treated at the same time in one or more facial area, to reach the 5 evaluations per area, the number of subjects to enrol may vary in every follow-up period.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Rose Pharma SA: lead

Study Sites (1)

Clinica Capitanio - Istituto Auxologico Italiano IRCCS Milano

Milan, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 11, 2023
• Study Start: June 30, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

IT (1)