Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation
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|ClinicalTrials.gov Identifier: NCT03537456|
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : October 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Facial Rejuvenation||Device: mRDX-02-17||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|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)|
|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|
|Actual Study Start Date :||October 29, 2018|
|Actual Primary Completion Date :||February 14, 2019|
|Actual Study Completion Date :||February 24, 2019|
mRDX-02-17 is a dermal filler recommended for correction and treatment of wrinkles and dermal depressions, which are administered by intradermal injections. It encourages repair and restructuring of skin tissue, reducing the signs of aging and has the following indications:
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.
- Wrinkle Severity Rating Scale (WSRS) Score [ Time Frame: 90 days ]The Wrinkle Severity Rating Scale is a 5-grade score scale, evaluating the severity of the facial wrinkles and comprising descriptive answers, numbered from 1 to 5. The best possible answer is 1 (no folds, continuos skin line) and the worst possible answer is 5 (extremely deep and long folds). This scale is evaluated by an investigator
- Wrinkle Severity Rating Scale (WSRS) Score [ Time Frame: 0, 15, 30, 45, 60 and 90 days ]The Wrinkle Severity Rating Scale is a 5-grade score scale, evaluating the severity of the facial wrinkles and comprising descriptive answers, numbered from 1 to 5. The best possible answer is 1 (no folds, continuos skin line) and the worst possible answer is 5 (extremely deep and long folds). This scale is evaluated by the subject.
- Global Aesthetic Improvement Scale (GAIS) Score [ Time Frame: 15, 30, 45, 60 and 90 days ]The Global Aesthetic Improvement Scale is a 5-grade score scale, evaluating the general appearance, comprising descriptive answers, numbered from 1 to 5. The best possible answer is 1 (optimal cosmetic result) and the worst possible answer is 5 (the appearance is worse than the original condition). This scale is evaluated by the subject.
- Treatment Satisfaction [ Time Frame: 30 and 90 days ]Questionnaire related to Treatment satisfaction assessed by the subject
- Choice of Recommendation [ Time Frame: 90 days ]The choice of recommending further the treatment will be assessed by the subject at the final visit. It includes a 3-point scale. The subject must evaluate the treatment from the perspective of recommending it further by marking one of the the following answers: yes, perhaps or no.
- Number of adverse events [ Time Frame: 0, 15, 30, 45, 60 and 90 days ]Collection of adverse events during each visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537456
|Hyperclinica Medlife Sucursala Timisoara|
|Timisoara, Romania, 300551|
|Societatea Civila Medicala Doctor Rosu|
|Timişoara, Romania, 300209|
|Study Director:||Luis Luis, MD||Medical Affairs Director|