Facial RejuvenationNCT04643977
Assessment of the Safety and Efficacy of the Dermal Filler "mARG-01-17" in Facial Rejuvenation Therapy
A study testing mARG-01-17 (mesohyal AGRIBENONE) in people with Facial Rejuvenation, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Rejuvenation
- What is being tested?
- mARG-01-17 (mesohyal AGRIBENONE)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Aug 2018to 18 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Facial Rejuvenation
- Being tested
- mARG-01-17 (mesohyal AGRIBENONE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mARG-01-17 (mesohyal AGRIBENONE)Device
Dermal Filler
| Study group | Role | What they receive |
|---|---|---|
| mesohyal ARGIBENONE | Experimental | 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. Receives: Device: mARG-01-17 (mesohyal AGRIBENONE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in Global Aesthetic Improvement Scale (GAIS)
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.
Measured: Between Day 0 to Day 90 (up to 12 weeks)
Safety endpoint
The frequency and severity of adverse events (AEs)
Measured: Between Day 0 to Day 90
Secondary outcomes (3)
The absolute change in Global Aesthetic Improvement Scale (GAIS)
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.
Measured: 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)
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.
Measured: Between Day 0 and Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
Subject satisfaction
A subject questionnaire including 5 point scale to evaluate the participant's satisfaction - 1 being very much improved and 5 - worsened.
Measured: Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start30 Aug 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial RejuvenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoestetic Pharma Group S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatyana Bayateva, MD, Principal investigator, Medical Center Asklepii" OOD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643977
- Sponsor's protocol ID
- MD/mARG-06-04-2018
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04643977
- Acronym / sponsor ID
- MD/mARG-06-04-2018
- Conditions
- Facial Rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mesoestetic Pharma Group S.L.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesohyal ARGIBENONE | Experimental | Device: mARG-01-17 (mesohyal AGRIBENONE)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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mARG-01-17 (mesohyal AGRIBENONE)Dermal Filler | Device | mesohyal ARGIBENONE |
Primary outcome
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.
Safety endpoint
Time frame: Between Day 0 to Day 90
The frequency and severity of adverse events (AEs)
3 secondary outcomes
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)
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)
Subject satisfaction
Time frame: Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatyana Bayateva, MD principal investigator
Medical Center Asklepii" OOD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mARG-01-17 (mesohyal AGRIBENONE) in people with Facial Rejuvenation, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute change in Global Aesthetic Improvement Scale (GAIS) (time frame: Between Day 0 to Day 90 (up to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.