Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04650620
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2020-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®
Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Organization:
Study Overview
Official Title:
Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerized Polynucleotides Dermal Filler) in the Correction of Wrinkles and Improving the Skin Tones and Irregularities (Atrophies) of the Skin Surface in Neck, Abdomen, Thighs, and Buttocks
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Plenhyage
Brief Summary:
The Research Question of the present study is the following: in a population of men and women affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks, will Plenhyage® significantly decrease the appearance of treated areas, results observed after 8 and 12 weeks?
Detailed Description:
Open, non-comparative, interventional, multicenter study with the total number of screened subjects of 66 (60 evaluable subjects +6 potential screening failure):
* 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles;
* 20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles;
* 20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;
* 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles;
* 20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles;
* 20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;
Study Oversight
Has Oversight DMC:
False
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?: