Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04546152
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2020-08-26
Brief Title:
Safety and Efficacy of the HA-based Dermal Fillers HYAPROF SOFT and HYAPROF BALANCE
Sponsor:
BioSCIENCE GmbH
Organization:
BioSCIENCE GmbH
Study Overview
Official Title:
Prospective Observational Clinical Trial for Safety and Efficacy of HYAPROF SOFT and HYAPROF BALANCE
Status:
COMPLETED
Status Verified Date:
2023-03
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:
PMCF_HYAPROF
Brief Summary:
Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAPROF SOFT and HYAPROF BALANCE for restoration of the facial volume and contour
Detailed Description:
This is a prospective multicenter observational open label two-arm crossover PMCF clinical trial for demonstration of the safety and efficacy of the HA-based dermal fillers HYAPROF SOFT and HYAPROF BALANCE for restoration of the facial volume and contour Besides safety aspects evaluated immediately after the treatment 4 weeks 3 and 6 months after the treatment the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using GAIS and WSRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None