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

NCT03537456 | Completed

• 1 other identifier: OPMES/0118/MD
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Facial Rejuvenation

Keywords

Dermal Filler; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• Wrinkle Severity Rating Scale (WSRS) Score

  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 Outcomes (4)

• Wrinkle Severity Rating Scale (WSRS) Score

  0, 15, 30, 45, 60 and 90 days

• Global Aesthetic Improvement Scale (GAIS) Score

  15, 30, 45, 60 and 90 days

• Treatment Satisfaction

  30 and 90 days

• Choice of Recommendation

  90 days

Other Outcomes (1)

• Number of adverse events

  0, 15, 30, 45, 60 and 90 days

Study Arms (1)

mRDX-02-17

EXPERIMENTAL

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

Interventions

mRDX-02-17 DEVICE

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.

mRDX-02-17

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (2)

Societatea Civila Medicala Doctor Rosu

Timișoara, 300209, Romania

Location

Hyperclinica Medlife Sucursala Timisoara

Timișoara, 300551, Romania

Location

Related Publications (30)

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Study Officials

• Luis Luis, MD

  Medical Affairs Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: October 29, 2018
• Primary Completion: February 14, 2019
• Study Completion: February 24, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

RO (2)