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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mARG-01-17 (mesohyal AGRIBENONE) | Device | Dermal Filler |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 and Days 15, 30, 45, 60 (up to 2, 4, 6 and 8 weeks respectively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatyana Bayateva, MD | Medical Center Asklepii" OOD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Medical Center Asklepii" OOD | Dupnitsa | Bulgaria |
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| 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. |
| 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. | Days 15, 30, 45, 60 and 90 (up to 2, 4, 6, 8 and 12 weeks respectively) |