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

NCT05239117 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-10-25

No results posted yet for this study

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

Interventions

DEVICE

Plenhyage

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.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • I.R.A. Istituto Ricerche Applicate S.p.A.

    lead NETWORK

Principal Investigators

  • Mihaela Fratila · SCM Dr. Rosu

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05239117 on ClinicalTrials.gov