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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
Sponsor:
Collaborator:
Opera CRO, a TIGERMED Group Company
Information provided by (Responsible Party):
Mesoestetic Pharma Group S.L.

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.


Condition or disease Intervention/treatment Phase
Facial Rejuvenation Device: mRDX-02-17 Not Applicable

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.


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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)
Primary Purpose: Treatment
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

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Treatment Satisfaction [ Time Frame: 30 and 90 days ]
    Questionnaire related to Treatment satisfaction assessed by the subject

  4. 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.


Other Outcome Measures:
  1. Number of adverse events [ Time Frame: 0, 15, 30, 45, 60 and 90 days ]
    Collection of adverse events during each visit



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Romania
Hyperclinica Medlife Sucursala Timisoara
Timisoara, Romania, 300551
Societatea Civila Medicala Doctor Rosu
Timişoara, Romania, 300209
Sponsors and Collaborators
Mesoestetic Pharma Group S.L.
Opera CRO, a TIGERMED Group Company
Investigators
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Study Director: Luis Luis, MD Medical Affairs Director

Publications:
The European Medical Device Regulations Annex VIII. Classification rules. April 2017.
ISO 14155:2011. Clinical investigation of medical devices for human subjects - Good clinical practice.
Almeida A, Sampaio G. Hyaluronic acid in the rejuvenation of the upper third of the face: review and update - Part 1. 2018.
Freedberg et al. Fitzpatrick's Dermatology In General Medicine (Two Vol. Set) 6th edition (May 23, 2003)
ISO 14971:2012 Medical devices. Application of risk management to medical devices.
ISO 13485:2016. Medical device - Quality management system- Requirements for regulatory purposes.
ISO 10993: 2009. Part1. Biological evaluation of medical devices.
ISO 14644: 2015 Part 1. Clean rooms and associated controlled environments.
ISO 17665-1:2006. Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
MEDDEV 2.7/3 revision 3 Clinical Investigations: Serious Adverse Event Reporting Under Directives 90/385/EEC and 93/42/EEC.

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Responsible Party: Mesoestetic Pharma Group S.L.
ClinicalTrials.gov Identifier: NCT03537456     History of Changes
Other Study ID Numbers: OPMES/0118/MD
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mesoestetic Pharma Group S.L.:
Dermal Filler
Hyaluronic Acid
Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents