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

Brief Title

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

Official Title

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

Brief Summary

      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

      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

Primary Outcome

POSAS score assessed by Investigator and patient

Secondary Outcome

 Global Aesthetic Improvement Scale evaluated by the patient (GAIS)

Condition

Cicatrix

Intervention

Auralya

Study Arms / Comparison Groups

 Auralya 1

Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

48

Start Date

March 21, 2022

Completion Date

December 11, 2022

Primary Completion Date

December 11, 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Mihaela Fratila, , 

Location Countries

Romania

Location Countries

Romania

NCT ID

NCT05239130

Organization ID

OPIRA/0421/MD

Responsible Party

Sponsor

Study Sponsor

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

Collaborators

 Opera CRO, a TIGERMED Group Company

Study Sponsor

Mihaela Fratila, Principal Investigator, SCM Dr. Rosu

Verification Date

April 2022