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

NCT04643977 | Completed

• 1 other identifier: MD/mARG-06-04-2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facial Rejuvenation

Outcome Measures

Primary Outcomes (2)

• 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.

  Between Day 0 to Day 90 (up to 12 weeks)

• Safety endpoint

  The frequency and severity of adverse events (AEs)

  Between Day 0 to Day 90

Secondary Outcomes (3)

• The absolute change in Global Aesthetic Improvement Scale (GAIS)

  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)

  Between Day 0 and Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)

• Subject satisfaction

  Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)

Study Arms (1)

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.

Device: mARG-01-17 (mesohyal AGRIBENONE)

Interventions

mARG-01-17 (mesohyal AGRIBENONE) DEVICE

Dermal Filler

mesohyal ARGIBENONE

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
• Refusal to sign the Informed Consent Form.

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead

Study Sites (1)

"Medical Center Asklepii" OOD

Dupnitsa, Bulgaria

Location

Study Officials

• Tatyana Bayateva, MD

  Medical Center Asklepii" OOD

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: November 25, 2020
• Study Start: August 30, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)