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

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.