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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dermal Filler
"Medical Center Asklepii" OOD
Dupnitsa, Bulgaria
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.
Time frame: Between Day 0 to Day 90 (up to 12 weeks)
Safety endpoint
The frequency and severity of adverse events (AEs)
Time frame: Between Day 0 to Day 90
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.
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)
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.
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
A subject questionnaire including 5 point scale to evaluate the participant's satisfaction - 1 being very much improved and 5 - worsened.
Time frame: Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively)
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