- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04643977
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
40
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
-
-
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Dupnitsa, Bulgaria
- "Medical Center Asklepii" OOD
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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
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 |
Intervention / Treatment |
---|---|
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.
|
Dermal Filler
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What is the study measuring?
Primary Outcome Measures
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.
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Between Day 0 to Day 90 (up to 12 weeks)
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Safety endpoint
Time Frame: Between Day 0 to Day 90
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The frequency and severity of adverse events (AEs)
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Between Day 0 to Day 90
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Secondary Outcome Measures
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.
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Between Day 0 and Days 15, 30, 45, 60 (up to 2, 4, 6 and 8 weeks respectively)
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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)
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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.
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Between Day 0 and Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
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Subject satisfaction
Time Frame: Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
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A subject questionnaire including 5 point scale to evaluate the participant's satisfaction - 1 being very much improved and 5 - worsened.
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Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
August 30, 2018
Primary Completion (Actual)
December 18, 2018
Study Completion (Actual)
December 18, 2018
Study Registration Dates
First Submitted
February 20, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 25, 2020
Study Record Updates
Last Update Posted (Actual)
November 25, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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