Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT03537456
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2018-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation
Sponsor:
Mesoestetic Pharma Group S.L.
Organization:
Study Overview
Official Title:
A Multicentre, Open-label, Interventional, Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation
Status:
COMPLETED
Status Verified Date:
2019-09
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:
mRDX-02-17 is a device for facial beauty care composed of hyaluronic acid in a concentration of 1.5% (p/v), as a functional ingredient, recommended for the correction and treatment of wrinkles and dermal depressions.
The primary hypothesis of this clinical investigation is that, at 30 days after the 60 days of treatment with mRDX-02-17, the mean WSRS score assessed by the investigator will decrease with at least 0.5 points compared to baseline evaluation.
The primary hypothesis of this clinical investigation is that, at 30 days after the 60 days of treatment with mRDX-02-17, the mean WSRS score assessed by the investigator will decrease with at least 0.5 points compared to baseline evaluation.
Detailed Description:
Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred by an increasing number of specialists in Aesthetics due to their clinical performance regarding volume restoration and favorable safety profile.
An evaluation of pre-clinical data was performed before the clinical investigation design.
Similar dermal fillers have been used in several clinical investigations in humans with a good rate of clinical success and good safety profiles.
During January - March 2018, review of the scientific literature was performed, to find similar investigations to determine the minimal clinically significant difference between Baseline and a period of 30 days after the end the treatment.
Considering the exploratory nature of this study and the fact that this investigation is first-in-human, the clinical investigation is designed to have a number of 7 study visits and a treatment period of 60 days.
In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits.
The primary objectives included in the present clinical investigation are the performance of the medical device in terms of absolute change of Wrinkle Severity Rating Scale (WSRS) score assessed by Investigator at 90 days after the initiation of treatment with mRDX-02-17 dermal filler, compared to Baseline Visit (day 0), and overall safety of the medical device.
An evaluation of pre-clinical data was performed before the clinical investigation design.
Similar dermal fillers have been used in several clinical investigations in humans with a good rate of clinical success and good safety profiles.
During January - March 2018, review of the scientific literature was performed, to find similar investigations to determine the minimal clinically significant difference between Baseline and a period of 30 days after the end the treatment.
Considering the exploratory nature of this study and the fact that this investigation is first-in-human, the clinical investigation is designed to have a number of 7 study visits and a treatment period of 60 days.
In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits.
The primary objectives included in the present clinical investigation are the performance of the medical device in terms of absolute change of Wrinkle Severity Rating Scale (WSRS) score assessed by Investigator at 90 days after the initiation of treatment with mRDX-02-17 dermal filler, compared to Baseline Visit (day 0), and overall safety of the medical device.
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?: