Clinical trial NCT05239117: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrix
Lipodystrophy
Plaque
Lead sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
Sponsor class: NETWORK
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2022-02-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center, open-label, non-randomized clinical investigation
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: POSAS score assessed by Investigator and patient
timeFrame: 8 weeks
measure: POSAS score assessed by Investigator and patient
timeFrame: 4 weeks
measure: POSAS score assessed by Investigator and patient
timeFrame: 12 weeks
measure: Investigator Global Assessment of Performance (IGAP)
timeFrame: 12 weeks
measure: Adverse Event incidence
timeFrame: 12 weeks
measure: Serious Adverse Event incidence
timeFrame: 12 weeks
measure: Adverse Device Event incidence
timeFrame: 12 weeks
measure: Serious Adverse Device Event incidence
timeFrame: 12 weeks
measure: Device deficiency incidence
timeFrame: 12 weeks
Secondary outcomes:
measure: Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
timeFrame: 12 weeks
measure: Treatment satisfaction assessment by the patient
timeFrame: 12 weeks
measure: Investigator Global Assessment of Safety (IGAS)
timeFrame: 12 weeks
measure: Patient Global Assessment of Safety (PGAS).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: SCM Dr. Rosu
state: Timis
Study officials:
affiliation: SCM Dr. Rosu
name: Mihaela Fratila
role: PRINCIPAL_INVESTIGATOR
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