Clinical trial NCT03537456: Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Rejuvenation
Keywords: Dermal Filler
Hyaluronic Acid
Lead sponsor: Mesoestetic Pharma Group S.L.
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2018-05-25
Enrollment: 39
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) Score
timeFrame: 90 days
Secondary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) Score
timeFrame: 0, 15, 30, 45, 60 and 90 days
measure: Global Aesthetic Improvement Scale (GAIS) Score
timeFrame: 15, 30, 45, 60 and 90 days
measure: Treatment Satisfaction
timeFrame: 30 and 90 days
measure: Choice of Recommendation
timeFrame: 90 days
Other outcomes:
measure: Number of adverse events
timeFrame: 0, 15, 30, 45, 60 and 90 days
Locations:
city: Timisoara
country: Romania
facility: Hyperclinica Medlife Sucursala Timisoara
city: Timişoara
country: Romania
facility: Societatea Civila Medicala Doctor Rosu
Study officials:
affiliation: Medical Affairs Director
name: Luis Luis, MD
role: STUDY_DIRECTOR
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