Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT03537456
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.
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.
Study:
NCT03537456
Study Brief:
Protocol Section:
NCT03537456