Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425955
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2018-02-02
Brief Title:
Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points Half - Face Method Within Subjects
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points Half - Face Method Within Subjects
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Aesthetic performance of SUNEKOS 200 injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded oval or squared face and in thin subjects with oval or triangular face and sagging skinInterstitial or cushion technique in comparison to bolus technique at five points half - face method within subjects
Detailed Description:
Spontaneous open clinical trial conducted by one centre under dermatological control Primary end point of the study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance of SUNEKOS 200 injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded oval or squared face and in thin subjects with oval or triangular face and sagging skin
The micro-injections of the study product were executed by a specialized dermatologist on the face of female volunteers with photoaging of mildmoderate grade to improve the treatment aesthetic performance two different injection techniques were carried out mono-laterally on the left or right face side randomly interstitial fluid technique IFT for the 1st subjects typology aged 35-50 years and cushion technique in association to retrograde interstitial fluid technique RIFT for the 2nd aged 45-60 On the contralateral face side the injection treatment was performed by bolus technique on five pre-determined face points preceding for the 2nd subjects typology by cushion technique
It was also aim of this study to evaluate tolerance both by investigator and volunteers and efficacy by the volunteers
The micro-injections of the study product were executed by a specialized dermatologist on the face of female volunteers with photoaging of mildmoderate grade to improve the treatment aesthetic performance two different injection techniques were carried out mono-laterally on the left or right face side randomly interstitial fluid technique IFT for the 1st subjects typology aged 35-50 years and cushion technique in association to retrograde interstitial fluid technique RIFT for the 2nd aged 45-60 On the contralateral face side the injection treatment was performed by bolus technique on five pre-determined face points preceding for the 2nd subjects typology by cushion technique
It was also aim of this study to evaluate tolerance both by investigator and volunteers and efficacy by the volunteers
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?:
None