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
December 30, 2022
Primary Completion Date
December 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, ,
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