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

October 24, 2022 updated by: I.R.A. Istituto Ricerche Applicate S.p.A.

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

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?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timişoara, Timis, Romania, 300425
        • SCM Dr. Rosu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women with age ≥ 18 and ≤ 65 years.
  2. 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.
  3. Patients who agree to discontinue any other dermatological treatment and procedures during the study.
  4. Patients willing to provide signed informed consent to clinical investigation participation.
  5. Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

  1. Past or current bleeding disorders.
  2. Use of aspirin and antiplatelet agents a week prior to treatment.
  3. 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.).
  4. Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
  5. History of anaphylaxis or severe complicated allergy symptoms.
  6. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
  7. Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1.
  8. Evidence or history of autoimmune disease or compromised immune system.
  9. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation.
  10. Prior permanent fillers or fat graft procedures around facial dermal tissue defects.
  11. 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.
  12. History of hypersensitivity to local anaesthetic of amide type or HA.
  13. History of keloid formation or hypertrophic scar on the face.
  14. Evidence of active infection on the face.
  15. Wound, skin disorder or infection around facial dermal tissue defects that may affect the efficacy assessment.
  16. 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.).
  17. Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment.
  18. Need to have direct or indirect contact with quaternary ammonium salts during the study.
  19. 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.
  20. 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.
  21. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Auralya 1
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
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.
EXPERIMENTAL: Auralya 2
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
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.
EXPERIMENTAL: Auralya 3
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment of Performance (IGAP)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
POSAS score assessed by Investigator and patient
Time Frame: 8 weeks
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
Time Frame: 4 weeks
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
Time Frame: 12 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
Time Frame: 12 weeks
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
Patient Global Assessment of Safety (PGAS)
Time Frame: 12 weeks
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
Treatment satisfaction assessment by the patient
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.A. Istituto Ricerche Applicate S.p.A.

Collaborators

Opera CRO, a TIGERMED Group Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2022

Primary Completion (ANTICIPATED)

December 11, 2022

Study Completion (ANTICIPATED)

December 11, 2022

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (ACTUAL)

February 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPIRA/0421/MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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