Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects

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Brief Title

Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects

Official Title

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

Brief Summary

      The Research Question of the present study is the following: in a population of men and women
      presenting facial and neck dermal tissue defects (scars, hypertrophic scars, depressed
      plaques, and lipodystrophy defects) will linear hyaluronic acid (Jalucomplex®) significantly
      decrease and / or improve their appearance, results observed after 4 and 8 weeks?
    

Detailed Description

      Jalucomplex® 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. Linear hyaluronic acid is a
      polymer that represents one of the essential components of human skin, subcutaneous and
      connective tissue; its ability to form complexes with water molecules increases the level of
      tissue hydration, turgidity and plasticity. These characteristics allow Jalucomplex® 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. Non-crosslinked hyaluronic acid generates a lower reactivity that
      crosslinked forms, biocompatibility of hyaluronic acid-based materials decreasing with an
      increase in the number of modifications to this polysaccharide
    


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

Jalucomplex

Study Arms / Comparison Groups

 Jalucomplex 1
Description:  Sixteen patients will be administered Jalucomplex® 1 for the treatment of minor-sized facial and neck dermal tissue defects (scars, hypertrophic 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 Information


Recruitment Status

Device

Estimated Enrollment

48

Start Date

March 7, 2022

Completion Date

July 22, 2022

Primary Completion Date

June 11, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Men or women with age ≥ 18 and ≤ 65 years.

          2. Patients with facial and neck dermal tissue defects (scars, hypertrophic scars,
             depressed plaques, and lipodystrophy defects), caused both by pathologies or trauma,
             seeking tissue augmentation treatment and willing to receive HA 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 and the neck (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 and neck dermal tissue
             defects.

         11. Facial and neck 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 on the face and the neck.

         14. Evidence of active infection on the face and the neck.

         15. Wound, skin disorder or infection around facial and neck dermal tissue 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, +40 740 211 991, frățilă[email protected]

Location Countries

Romania

Location Countries

Romania

Administrative Informations


NCT ID

NCT05239351

Organization ID

OPIRA/0321/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

March 2022