NCT05239351

Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Jalucomplex® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial and Neck Dermal Tissue Defects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A. · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Research Question of the present study is the following: in a population of men and women presenting facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) will linear hyaluronic acid (Jalucomplex®) significantly decrease and / or improve their appearance, results observed after 4 and 8 weeks?

Detailed description

Jalucomplex® action is to increase the volume of dermal-epidermal tissue, based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times greater than their weight. This allows to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. Linear hyaluronic acid is a polymer that represents one of the essential components of human skin, subcutaneous and connective tissue; its ability to form complexes with water molecules increases the level of tissue hydration, turgidity and plasticity. These characteristics allow Jalucomplex® 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. Non-crosslinked hyaluronic acid generates a lower reactivity that crosslinked forms, biocompatibility of hyaluronic acid-based materials decreasing with an increase in the number of modifications to this polysaccharide

Conditions

• Cicatrix
• Lipodystrophy
• Plaque

Interventions

Type	Name	Description
DEVICE	Jalucomplex	Device: Jalucomplex Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.

Timeline

• Start date: 2022-03-07
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2022-02-14
• Last updated: 2022-10-24

Locations

1 site across 1 country: Romania