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
Overview
- Phase
- Not Applicable
- Sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Adverse Event incidence
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women with age ≥ 18 and ≤ 65 years.
- •Patients presenting dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects), seeking tissue augmentation treatment and willing to receive Polymerized Polynucleotides Filler.
- •Patients who agree to discontinue any other dermatological treatment and procedures during the study.
- •Patients willing to provide signed informed consent to clinical investigation participation.
- •Patients able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Exclusion Criteria
- •Use of aspirin and antiplatelet agents a week prior to treatment.
- •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
- •Patients with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc..
- •Patients presenting bleeding disorders in the past or present.
- •Patients taking or having indications for anticoagulant therapy.
- •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.
- •Patients suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus.
- •Patients suffering from active eczema, acne and keloids.
- •Patients with any cutaneous manifested infection, disease or alteration.
- •Patients at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device.
Outcomes
Primary Outcomes
Adverse Event incidence
Time Frame: 12 weeks
To evaluate the safety of the device through Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
POSAS score assessed by Investigator and patient
Time Frame: 12 weeks
To evaluate the overall performance of the medical dermal filler Plenhyage® in treating dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects) in terms of change in Patient and Observer Scar Assessment Scale (POSAS) score \[Draaijers, 2004; van de Kar, 2005\], assessed by Investigators and patients at 12 weeks (84 days) after the initiation of treatment, compared to Visit 1 (day 0)
Investigator Global Assessment of Performance (IGAP)
Time Frame: 12 weeks
To evaluate the global performance of product assessed by Investigator through photos taken at each visit (IGAP), at week 12 (day 84), compared to Visit 1 (day 0)
Serious Adverse Event incidence
Time Frame: 12 weeks
To evaluate the safety of the device through Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Adverse Device Event incidence
Time Frame: 12 weeks
To evaluate the safety of the device through Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation
Serious Adverse Device Event incidence
Time Frame: 12 weeks
To evaluate the safety of the device through Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation
Device deficiency incidence
Time Frame: 12 weeks
To evaluate the safety of the device through Device deficiency incidence assessed by Investigators at all visits and reported according to the current legislation
Secondary Outcomes
- Global Aesthetic Improvement Scale evaluated by the patient (GAIS)(12 weeks)
- Treatment satisfaction assessment by the patient(12 weeks)
- Investigator Global Assessment of Safety (IGAS)(12 weeks)
- Patient Global Assessment of Safety (PGAS).(12 weeks)