Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation

September 30, 2019 updated by: Mesoestetic Pharma Group S.L.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Timisoara, Romania, 300551
        • Hyperclinica Medlife Sucursala Timisoara
      • Timişoara, Romania, 300209
        • Societatea Civila Medicala Doctor Rosu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women with age > 35 and ≤ 65 years;
  • Subjects seeking tissue augmentation treatment on the face;
  • Subjects willing to receive HA Filler for one and/or more mimetic and/or superficial facial wrinkles located in the facial area including periocular area;
  • Subjects willing to receive HA Filler for one and/or more mimetic and/or superficial facial wrinkles;
  • Subjects willing to provide signed informed consent to clinical investigation participation.

Exclusion Criteria:

  • Use of aspirin and antiplatelet agents a week prior to treatment;
  • Pregnant or lactating women;
  • Subjects with a history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler;
  • Subjects with hypersensitivity to salicylic acid or any of its derivates;
  • Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.;
  • Subjects presenting bleeding disorders in the past or present;
  • Subjects taking or having indications for anticoagulant therapy;
  • Use of concomitant treatments or procedures aimed to improve skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing;
  • Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus;
  • Subjects suffering from eczema, acne, and keloids;
  • Subjects with any cutaneous manifested infection, disease or alteration;
  • Subjects at risk in term of precautions, warnings, and contra-indications referred in the package insert of the clinical investigation device;
  • Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment;
  • Subjects with any active irritation or inflammation in the target areas of injection;
  • Subjects who received botulinum toxin A injections in the face in the preceding 6 months;
  • Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits;
  • Subjects with solar activity, such as prolonged exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment
  • Direct or indirect contact with quaternary ammonium salts during the investigation
  • Subjects participating in another clinical investigation or treated with another HA filler with the same indications at the same time or within the preceding 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRDX-02-17

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:

  • Hypotrophic tissues
  • Tissue hypotonicity
  • Crow's feet
  • Glogau III - IV
  • Fiztpatrick I - VI
  • WSRS (Wrinkle Severity Ranking Scale): 2-5
Device: mRDX-02-17

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 15, 30, 45, 60 and 90 days
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.
15, 30, 45, 60 and 90 days
Treatment Satisfaction
Time Frame: 30 and 90 days
Questionnaire related to Treatment satisfaction assessed by the subject
30 and 90 days
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.
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 0, 15, 30, 45, 60 and 90 days
Collection of adverse events during each visit
0, 15, 30, 45, 60 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoestetic Pharma Group S.L.

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Study Director: Luis Luis, MD, Medical Affairs Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Actual)

February 14, 2019

Study Completion (Actual)

February 24, 2019

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPMES/0118/MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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