Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects

Study Overview
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Brief Summary
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The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Auralya®) significantly decrease and / or improve their appearance, results observed after 4, 8 and 12 weeks?

Detailed Description
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Auralya® action is to increase the volume of dermal-epidermal tissue based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times greater than their weight. This allows to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. These characteristics allow Auralya® to be used as a temporary filler for subcutaneous areas to correct small defects in the dermal tissue due to lipodystrophies or the presence of fibrotic tissues as scars, caused by pathologies or trauma.

Official Title
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Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Auralya® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects

Conditions
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Cicatrix, Lipodystrophy, Plaque

Intervention / Treatment
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* Device: Auralya


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women with age ≥ 18 and ≤ 65 years. Patients with facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects), caused by both pathologies or trauma, seeking tissue augmentation and skin imperfections treatment and willing to receive Hyaluronic Acid Filler. Patients who agree to discontinue any other dermatological treatment and procedures during the study. Patients willing to provide signed informed consent to clinical investigation participation. Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study. Exclusion Criteria: Past or current bleeding disorders. Use of aspirin and antiplatelet agents a week prior to treatment. Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.). Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening. History of anaphylaxis or severe complicated allergy symptoms. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study. Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1. Evidence or history of autoimmune disease or compromised immune system. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation. Prior permanent fillers or fat graft procedures around facial dermal tissue defects. Facial dermal tissue defects correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photo-rejuvenation, etc.) around infraorbital region within 6 months prior to study participation. History of hypersensitivity to local anaesthetic of amide type or HA. History of keloid formation or hypertrophic scar on the face. Evidence of active infection on the face. Wound, skin disorder or infection around facial dermal tissue defects that may affect the efficacy assessment. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception* during the study. *Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.). Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment. Need to have direct or indirect contact with quaternary ammonium salts during the study. As with all dermal filler procedures, the product should not be used in vascular rich areas. Using the product at sites such as Glabella and nose may inadvertently be injected into the blood vessels, resulting in symptom of vessel occlusion such as colour vision deficiency and blindness. Patients with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-center, open-label, non-randomized clinical investigation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auralya 1<br>Sixteen patients will be administered Auralya® 1 (Cross-linked Hyaluronic Acid) for the treatment of minor facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects). | Device: Auralya<br>* Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. Auralya® is a colourless gel contained in a pre-filled, graduated, disposable, and sterile glass syringe with a Luer adapter.<br>|
| Experimental: Auralya 2<br>Sixteen patients will be administered Auralya® 2 (Cross-linked Hyaluronic Acid) for the treatment of medium-sized facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects). | Device: Auralya<br>* Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. Auralya® is a colourless gel contained in a pre-filled, graduated, disposable, and sterile glass syringe with a Luer adapter.<br>|
| Experimental: Auralya 3<br>Sixteen patients will be administered Auralya® 3 (Cross-linked Hyaluronic Acid) for the treatment of major facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects). | Device: Auralya<br>* Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. Auralya® is a colourless gel contained in a pre-filled, graduated, disposable, and sterile glass syringe with a Luer adapter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSAS score assessed by Investigator and patient | To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients 8 weeks (56 days) after the initiation of treatment, compared to Visit 1 (day 0) | 8 weeks | 
| POSAS score assessed by Investigator and patient | To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients at 4 weeks (28 days) after the initiation of treatment, compared to Visit 1 (day 0) | 4 weeks | 
| POSAS score assessed by Investigator and patient | To evaluate the overall performance of the medical dermal filler Auralya® in treating facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score [Draaijers, 2004; van de Kar, 2005], assessed by Investigators and patients at 12 weeks (84 days) after the initiation of treatment, compared to Visit 1 (day 0) | 12 weeks | 
| Investigator Global Assessment of Performance (IGAP) | To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 12 (day 84), compared to Visit 1 (day 0) | 12 weeks | 
| Adverse Event incidence | To evaluate the safety of the device through Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation | 12 weeks | 
| Serious Adverse Event incidence | To evaluate the safety of the device through Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation | 12 weeks | 
| Adverse Device Event incidence | To evaluate the safety of the device through Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation | 12 weeks | 
| Serious Adverse Device Event incidence | To evaluate the safety of the device through Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement Scale evaluated by the patient (GAIS) | To evaluate general appearance after treatment assessed by the patient at 4, 8 and 12 weeks (28, 56 and 84 days) using the Global Aesthetic Improvement Scale (GAIS) [Kim, 2016], [Kopera, 2015 - 2018], [McCall-Perez, 2011], [Savoia, 2015]. The scale evaluates the appearance from 1 (very much improved) to 5 (worse than original condition) . | 12 weeks | 
| Treatment satisfaction assessment by the patient | To assess the patient satisfaction at 4, 8 and 12 weeks (28, 56 and 84 days), providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied) [Few, 2015] | 12 weeks | 
| Investigator Global Assessment of Safety (IGAS) | To evaluate the global safety of product assessed by Investigator (IGAS), at week 12 (day 84), compared to Visit 1 (day 0) , providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety. | 12 weeks | 
| Patient Global Assessment of Safety (PGAS) | To evaluate the global safety of product assessed by the patient (PGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety. | 12 weeks |