NCT04103918

Evaluate The Performance And Safety Of The Medical Device Jalucomplex®

Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Jalucomplex® (Hyaluronic Acid-Dermal Filler) In the Treatment Of Facial And Neck Wrinkles To Obtain Facial Rejuvanation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A. · Network
• Sex: All
• Age: 35 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 affected by facial and neck wrinkles, will linear hyaluronic acid (Jalucomplex®) significantly decrease the appearance of facial and neck wrinkles, results observed after 12 weeks?

Detailed description

This is an open, non-comparative study for evaluating the performance and safety of the medical device Jalucomplex in the treatment of facial and neck wrinkles. Similar dermal fillers have been used in several clinical investigations in humans with a good rate of clinical success and good safety profiles. Jalucomplex®'s acts by increasing tissue volume based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water far greater than their own weight. This allows the material to fill intra-dermal spaces and supplement the intercellular matrix. 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.

Conditions

• Wrinkle

Interventions

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

Timeline

• Start date: 2020-08-24
• Primary completion: 2021-01-20
• Completion: 2021-01-20
• First posted: 2019-09-26
• Last updated: 2021-04-12

Locations

1 site across 1 country: Romania