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

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Brief Title

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

Official Title

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerised Polynucleotides Dermal Filler) in the Treatment of Dermal Tissue Defects

Brief Summary

      The Research Question of the present study is the following: in a population of men and women
      presenting dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy
      defects) will Plenhyage® significantly improve the appearance of treated areas, results
      observed after 4, 8 and 12 weeks?
    

Detailed Description

      Plenhyage® is a different type of dermal filler, an innovative course of polynucleotides to
      restore skin damage. The polynucleotide chain attracts water molecules, protecting against
      free radicals, acting as an absorber of hydroxyl radicals OH, which accumulate from stress,
      cell damage and UV rays. It also guarantees moisturising action and protection against free
      radicals. Nucleotides, natural fractions of DNA and RNA, are components of Plenhyage® with an
      antioxidant, protective effect. These characteristics allow Plenhyage® 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

Plenhyage

Study Arms / Comparison Groups

 Plenhyage Thin
Description:  Sixteen patients will be administered Plenhyage® Thin for the treatment of minor -sized dermal tissue defects (scars, atrophic 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 30, 2022

Completion Date

September 11, 2022

Primary Completion Date

July 30, 2022

Eligibility Criteria

        Inclusion Criteria:

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

          2. Patients presenting dermal tissue defects (scars, atrophic scars, depressed plaques,
             and lipodystrophy defects), seeking tissue augmentation treatment and willing to
             receive Polymerized Polynucleotides 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. Use of aspirin and antiplatelet agents a week prior to treatment.

          2. Patients with history of allergy or hypersensitivity to polymerised polynucleotides or
             to other ingredients of the dermal filler or hypersensitivity skin reaction to the
             investigational device based on intradermal test results at visit 1.

          3. Patients with any dermal systemic pathologies, such as systemic lupus erythematosus,
             psoriasis, scleroderma etc..

          4. Patients presenting bleeding disorders in the past or present.

          5. Patients taking or having indications for anticoagulant therapy.

          6. Use of concomitant treatments or procedures aimed to improve skin appearance over the
             last six months before the clinical investigation enrolment, such as chemical peeling,
             dermabrasion, laser resurfacing.

          7. Patients suffering from infectious diseases including herpes simplex virus infection,
             active hepatitis or human immunodeficiency virus.

          8. Patients suffering from active eczema, acne and keloids.

          9. Patients with any cutaneous manifested infection, disease or alteration.

         10. Patients at risk in term of precautions, warnings and contra-indications referred in
             the package insert of the clinical investigation device.

         11. Patients with any facial aesthetic surgery in the preceding 12 months before the
             clinical investigation enrolment

         12. Patients with any active irritation or inflammation in the target areas of injection.

         13. Patients who received botulinum toxin A injections in the face in the preceding 6
             months.

         14. Patients unlikely to cooperate in the clinical investigation or to comply with the
             treatment or with the clinical investigation visits.

         15. 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.).

         16. 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.

         17. 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

NCT05239117

Organization ID

OPIRA/0521/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