Facial Rejuvenation Clinical Trial
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
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.
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.
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