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

NCT05239117 | Unknown

• 1 other identifier: OPIRA/0521/MD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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?

Conditions

Cicatrix; Lipodystrophy; Plaque

Outcome Measures

Primary Outcomes (9)

• POSAS score assessed by Investigator and patient

  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 8 weeks ( 56 days) after the initiation of treatment, compared to Visit 1 (day 0)

  8 weeks

• POSAS score assessed by Investigator and patient

  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 4 (28 days) after the initiation of treatment, compared to Visit 1 (day 0)

  4 weeks

• POSAS score assessed by Investigator and patient

  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)

  12 weeks

• Investigator Global Assessment of Performance (IGAP)

  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)

  12 weeks

• Adverse Event incidence

  To evaluate the safety of the device through Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation

  12 weeks

• Serious Adverse Event incidence

  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

  12 weeks

• Adverse Device Event incidence

  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

  12 weeks

• Serious Adverse Device Event incidence

  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

  12 weeks

• Device deficiency incidence

  To evaluate the safety of the device through Device deficiency incidence assessed by Investigators at all visits and reported according to the current legislation

  12 weeks

Secondary Outcomes (4)

• 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

Study Arms (3)

Plenhyage Thin

EXPERIMENTAL

Sixteen patients will be administered Plenhyage® Thin for the treatment of minor -sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).

Device: Plenhyage

Plenhyage Medium

EXPERIMENTAL

Sixteen patients will be administered Plenhyage® Medium for the treatment of medium-sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).

Device: Plenhyage

Plenhyage Strong

EXPERIMENTAL

Sixteen patients will be administered Plenhyage® Strong for the treatment of major-sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).

Device: Plenhyage

Interventions

Plenhyage DEVICE

Plenhyage® is an elastic, sterile, injectable, non-pyrogenic, re-absorbable gel made with polymerised polynucleotides (PDRN) of animal origin (fish). Due to its hydrophilic and polyanionic nature, PDRN binds water molecules, thereby filling intradermal spaces and making tissues firmer and more hydrated. The polynucleotide chain binds water molecules, has an anti-free radical action, and serves as a scavenger of hydroxyl radicals (OH), which accumulate under stress or due to foreign agents, such as UV radiation. Its hydration and anti-free radical activity help create the optimal environment for fibroblast growth, thereby restoring tissue elasticity. Plenhyage® is a colourless gel contained in a pre-filled, graduated, disposable, and sterile syringe with a Luer Lok adapter.

Plenhyage Medium; Plenhyage Strong; Plenhyage Thin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 1.
• 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.
• Patients with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment
• Patients with any active irritation or inflammation in the target areas of injection.
• Patients who received botulinum toxin A injections in the face in the preceding 6 months.
• Patients unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
• 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.

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Dr. Rosu

Timișoara, Timiș County, 300425, Romania

Location

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MeSH Terms

Conditions

Cicatrix; Lipodystrophy; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical

Study Officials

• Mihaela Fratila

  SCM Dr. Rosu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a multi-center, open-label, non-randomized clinical investigation

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 14, 2022
• Study Start: March 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-04

Locations

RO (1)