Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT05239156
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2022-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects
Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Organization:
Study Overview
Official Title:
Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Janesse® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Janesse®) significantly decrease and / or improve the appearance of these defects, results observed after 4, 8 and 12 weeks?
Detailed Description:
Janesse® 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. The cross-linking of the hyaluronic acid contained in the product has the effect of more stable and durable filling over time. These characteristics allow Janesse® 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: