Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation
Condition: Facial Rejuvenation
MeSH terms: Facies
Study type: Interventional

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.
    

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.
    

Intervention name(s): mRDX-02-17
Intervention type(s): Device
Intervention description(s): mRDX -02-17 is a dermal filler recommended for the correction and treatment of wrinkles and dermal depressions.
It is a sterile and viscous aqueous solution of hyaluronic acid in a concentration of 1.5% (p/v) with acetyl tetrapeptide-9 and palmitoyl tripeptide-5, as auxiliary ingredients which is administrated by intradermal injections.
This medical device encourages repair and restructuring of skin tissue and reduces the signs of aging.
mRDX -02-17 is indicated for patients with hypotrophic tissues, Crow's feet, Glogau III-IV, all skin photo types (Fitzpatrick I - VI) and a WSRS score (Wrinkle Severity Ranking Scale) from 2 to 5.
Intervention model: Single Group Assignment
Intervention model description: mRDX-02-17 is recommended for correction and treatment of wrinkles and dermal depressions, when administered by intradermal injection.
This is a multi-center, open-label, non-randomized, single-group clinical investigation in subjects aged 35-65 years old seeking facial rejuvenation.
Because it is a medical device with an innovative composition and that it is a first-in-human investigation, we preferred an exploratory approach for the investigation design. The main objectives and clinical endpoints are the performance and the safety profile of the investigational device.
The total study duration will be approximately 3 months or 90 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dermal Filler; Hyaluronic Acid