Assessment of the Safety and Efficacy of the Dermal Filler "mARG-01-17" in Facial Rejuvenation Therapy

November 20, 2020 updated by: Mesoestetic Pharma Group S.L.

An Open-Label Uncontrolled Single Center Study for the Evaluation of the Efficacy and Safety of the Dermal Filler "mARG-01-17" in the Facial Rejuvenation Therapy

The aim of the clinical investigation is to evaluate the performance of the mARG-01-17 dermal filler in the context of its efficacy and safety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is an open-label uncontrolled single-center study for the evaluation of the Performance (efficacy and safety) of the dermal filler "mARG-01-17" in the facial rejuvenation therapy. The design is of a not blinded, not randomized, single group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Bulgaria
      • Dupnitsa, Bulgaria
        • "Medical Center Asklepii" OOD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects;
  • Age between ≥35 and ≤65 years;
  • Subjects with WSRS (Wrinkle Severity Ranking Scale) score between 2 and 3;
  • Skin phototype I - VI;
  • Subjects with Glogau score between I and III;
  • Subjects with either chrono and photoaging wrinkles, wrinkles of expression (Line of expression); Dry and dehydrated skin;
  • Subjects who are willing to abstain from any cosmetic or surgical procedures (including botox injection) in the treatment area during the clinical investigation;
  • Clinically and anamnestically healthy individual, especially absence of diseases that could interfere with the cutaneous aging evaluation;
  • Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;
  • Subjects without significant body weight fluctuation;
  • Non-smoker and smokers;
  • Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;
  • Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min;
  • Respiratory rate between 12 - 24 breaths/min;
  • Axillar body temperature of up to 370С;
  • Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
  • Negative AIDS/HIV test;
  • Negative pregnancy test for the women with reproductive potential;
  • Reliable and acceptable method of contraception for the women of child-bearing potential;
  • Signed written Informed Consent Form.

Exclusion Criteria:

  • Subjects who had previously received permanent implants on the treated area;
  • Subjects who underwent facial surgery or were injected with dermal fillers in the facial area within the previous 6 months before enrollment;
  • Subjects who underwent facial procedures such as laser therapy, chemical peeling, dermo-abrasive treatments, or botulinum toxin injection within 12 months before enrollment;
  • Subjects who indicate signs of dermatological problems, such as cutaneous lesions, acne and/or other inflammatory diseases in active phase, hypertrophic scars or a tendency to keloid formation;
  • Subjects suffering from systemic diseases or alterations, such as diabetes mellitus, connective tissue diseases, uncontrolled systemic diseases;
  • Subjects, suffering from or who have history of immune system disorders, such as autoimmune diseases, HIV positive status, history of immune system degradation or recurrent herpes simplex or who are undergoing treatment with immunosuppressors or immunotherapy;
  • Subjects with known allergy or hypersensitivity to salicylic acid or its derivatives, any of the components of the product or cosmetic fillers to hyaluronic acid;
  • Pregnant women;
  • Breastfeeding women;
  • Absence of a reliable and effective method of contraception;
  • Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;
  • Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit inclusion in the study;
  • Subjects with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
  • Refusal to sign the Informed Consent Form.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mesohyal ARGIBENONE
Name of the investigation medical device: mesohyal ARGIBENONE Code of the MD for the purpose of the clinical investigation: mARG-01-17 GMDN code: 59131 mARG-01-17 is a dermal filler recommended for cutaneous filling, facial wrinkle improvement and general condition of the skin, which is administered by intradermal injections. It encourages repair and restructuring of skin tissue, reducing the signs of aging.
Device: mARG-01-17 (mesohyal AGRIBENONE)
Dermal Filler

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The absolute change in Global Aesthetic Improvement Scale (GAIS)
Time Frame: Between Day 0 to Day 90 (up to 12 weeks)
A 5-point scale rating global aesthetic improvement in appearance, compared to pre-treatment, as judged by the Principal Investigator. Grade 1 - Exceptional improvement, grade 5 - Worsened.
Between Day 0 to Day 90 (up to 12 weeks)
Safety endpoint
Time Frame: Between Day 0 to Day 90
The frequency and severity of adverse events (AEs)
Between Day 0 to Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The absolute change in Global Aesthetic Improvement Scale (GAIS)
Time Frame: Between Day 0 and Days 15, 30, 45, 60 (up to 2, 4, 6 and 8 weeks respectively)
A 5-point scale rating global aesthetic improvement in appearance, compared to pre-treatment, as judged by the Principal Investigator. Grade 1 - Exceptional improvement, grade 5 - Worsened.
Between Day 0 and Days 15, 30, 45, 60 (up to 2, 4, 6 and 8 weeks respectively)
The change in Wrinkle Severity Ranking Scale (WSRS)
Time Frame: Between Day 0 and Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
A validated five-point reference scale with photographs for evaluation of the skin condition that classifies deep facial wrinkles, like the nasolabial folds. as judged by the Principal Investigator.Grade 1 - the Best result, grade 5 - being the worst result.
Between Day 0 and Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
Subject satisfaction
Time Frame: Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
A subject questionnaire including 5 point scale to evaluate the participant's satisfaction - 1 being very much improved and 5 - worsened.
Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mesoestetic Pharma Group S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tatyana Bayateva, MD, Medical Center Asklepii" OOD

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD/mARG-06-04-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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