Back to resultsEvaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects
Primary Purpose
Cicatrix, Lipodystrophy, Plaque
Status
Active
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Plenhyage
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix
Eligibility Criteria
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 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.
*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.).
- 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.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Sites / Locations
- SCM Dr. Rosu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Plenhyage Thin
Plenhyage Medium
Plenhyage Strong
Arm 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).
Sixteen patients will be administered Plenhyage® Medium for the treatment of medium-sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).
Sixteen patients will be administered Plenhyage® Strong for the treatment of major-sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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
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
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
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
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
Secondary Outcome Measures
Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
To evaluate general appearance after treatment assessed by the patient at 4, 8 and 12 weeks (28, 56 and 84 days) using the Global Aesthetic Improvement Scale (GAIS) [Kim, 2016], [Kopera, 2015 - 2018], [McCall-Perez, 2011], [Savoia, 2015]. The scale evaluates the appearance from 1 (very much improved) to 5 (worse than original condition) .
Treatment satisfaction assessment by the patient
To assess the patient satisfaction at 4, 8 and 12 weeks (28, 56 and 84 days), providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied)
Investigator Global Assessment of Safety (IGAS)
To evaluate the global safety of product assessed by Investigator (IGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Patient Global Assessment of Safety (PGAS).
To evaluate the global safety of product assessed by the patient (PGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Full Information
NCT ID
NCT05239117
First Posted
January 17, 2022
Last Updated
October 24, 2022
Sponsor
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
1. Study Identification
Unique Protocol Identification Number
NCT05239117
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Lipodystrophy, Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-center, open-label, non-randomized clinical investigation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plenhyage Thin
Arm Type
Experimental
Arm 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).
Arm Title
Plenhyage Medium
Arm Type
Experimental
Arm Description
Sixteen patients will be administered Plenhyage® Medium for the treatment of medium-sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).
Arm Title
Plenhyage Strong
Arm Type
Experimental
Arm Description
Sixteen patients will be administered Plenhyage® Strong for the treatment of major-sized dermal tissue defects (scars, atrophic scars, depressed plaques, and lipodystrophy defects).
Intervention Type
Device
Intervention Name(s)
Plenhyage
Intervention Description
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.
Primary Outcome Measure Information:
Title
POSAS score assessed by Investigator and patient
Description
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)
Time Frame
8 weeks
Title
POSAS score assessed by Investigator and patient
Description
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)
Time Frame
4 weeks
Title
POSAS score assessed by Investigator and patient
Description
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)
Time Frame
12 weeks
Title
Investigator Global Assessment of Performance (IGAP)
Description
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)
Time Frame
12 weeks
Title
Adverse Event incidence
Description
To evaluate the safety of the device through Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation
Time Frame
12 weeks
Title
Serious Adverse Event incidence
Description
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
Time Frame
12 weeks
Title
Adverse Device Event incidence
Description
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
Time Frame
12 weeks
Title
Serious Adverse Device Event incidence
Description
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
Time Frame
12 weeks
Title
Device deficiency incidence
Description
To evaluate the safety of the device through Device deficiency incidence assessed by Investigators at all visits and reported according to the current legislation
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Global Aesthetic Improvement Scale evaluated by the patient (GAIS)
Description
To evaluate general appearance after treatment assessed by the patient at 4, 8 and 12 weeks (28, 56 and 84 days) using the Global Aesthetic Improvement Scale (GAIS) [Kim, 2016], [Kopera, 2015 - 2018], [McCall-Perez, 2011], [Savoia, 2015]. The scale evaluates the appearance from 1 (very much improved) to 5 (worse than original condition) .
Time Frame
12 weeks
Title
Treatment satisfaction assessment by the patient
Description
To assess the patient satisfaction at 4, 8 and 12 weeks (28, 56 and 84 days), providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied)
Time Frame
12 weeks
Title
Investigator Global Assessment of Safety (IGAS)
Description
To evaluate the global safety of product assessed by Investigator (IGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Time Frame
12 weeks
Title
Patient Global Assessment of Safety (PGAS).
Description
To evaluate the global safety of product assessed by the patient (PGAS), at week 12 (day 84), compared to Visit 1 (day 0), providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
*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.).
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.
Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihaela Fratila
Organizational Affiliation
SCM Dr. Rosu
Official's Role
Principal Investigator
Facility Information:
Facility Name
SCM Dr. Rosu
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300425
Country
Romania
12. IPD Sharing Statement
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Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects
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