CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
mRDX-02-17device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03537456
NCT03537456N/ACompleted

A Multicentre, Open-label, Interventional, Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation

Mesoestetic Pharma Group S.L.·interventional·Posted May 25, 2018·Updated Oct 1, 2019

In Brief

A clinical study evaluating mRDX-02-17 for Facial Rejuvenation. Completed, enrolled 39 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRomania

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartOct 29, 2018
Primary CompletionFeb 14, 2019
Study CompletionFeb 24, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.1 years ago

Interventions

mRDX-02-17device

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.