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Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®

Wrinkle Clinical Trial

Official title:
Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device JANESSE® (Hyaluronic Acid-Dermal Filler) In The Correction Of Facial Wrinkles

Clinical Trial Summary

The hypothesis of this clinical investigation is that in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse) significantly decrease the appearance of facial wrinkles, results observed after 4, 8 and 12 weeks.

Clinical Trial Description

Janesse®'s 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 allow to fill the intradermal spaces and integrate the intercellular matrix, conferring turgidity to the tissues. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. The Research Question of the present study is the following: in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse®) significantly decrease the appearance of nasolabial wrinkles, results observed after 12 weeks? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04103125
Study type Interventional
Source I.R.A. Istituto Ricerche Applicate S.p.A.
Contact
Status Completed
Phase N/A
Start date July 14, 2020
Completion date December 21, 2020
View Details
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