Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age35 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects;
Age between ≥35 and ≤65 years;

Sponsors & Collaborators

Mesoestetic Pharma Group S.L.
Industrylead

Study Sites (1)

"Medical Center Asklepii" OOD

Dupnitsa, Bulgaria

Study Officials

Tatyana Bayateva, MD
Medical Center Asklepii" OOD
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

mesohyal ARGIBENONE

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

mesohyal ARGIBENONE

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations