The investigation is a single centre, interventional, prospective, non-randomized, open-label, uncontrolled, single arm, un-blinded investigation for evaluation of safety and performance of the medical device M-AOX-2021 in the treatment of wrinkles and imperfections. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
The product M-AOX-2021 is a dermal filler manufactured by mesoestetic Pharma Group s.l.. It was intended to be used as a temporary dermal filler for dermatological treatment for aesthetic purposes. The product corrects wrinkles and imperfections of the lower two thirds of the face, while also providing hydration and an antioxidant action to the skin. Мesofiller aox for facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable medical device made out of cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation. This clinical investigation was conducted as an uncontrolled - no comparator medical device or other product was used. The safety and performance of the treatment was evaluated by comparison of the condition with the state of the treated area before initiation of the procedure, conducted by the trained Principal Investigator. The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. The both sessions was conducted within 14 days interval. The process of the evaluation during the medical examination was facilitated by photographic evidence taken before and after therapy at a predetermined time points for reference.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. The both sessions was conducted within 14 days interval.
"Medical Center Ramus" EOOD
Sofia, Bulgaria
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Time frame: Two months after the first treatment (Session 3 (Day 60))
Modified Fitzpatrick Wrinkle Scale (MFWS) - principal investigator evaluation.
The absolute change in Modified Fitzpatrick Wrinkle Scale (MFWS) from baseline evaluated by the principal investigator based on the photographs of the treated area. MFWS is a wrinkle-scoring system for perioral and periorbital wrinkle severity, ranging from Class 1 Class 1 - mild to Class 3 - severe.
Time frame: Session 1 (Day 1), Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365).
Modified Fitzpatrick Wrinkle Scale (MFWS) - patient evaluation.
The absolute change in Modified Fitzpatrick Wrinkle Scale (MFWS) from baseline evaluated by the patient. MFWS is a wrinkle-scoring system for perioral and periorbital wrinkle severity, ranging from Class 1 Class 1 - mild to Class 3 - severe.
Time frame: Session 1 (Day 1), Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365).
Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation.
Improvement in the Global Aesthetic Improvement Scale as evaluated by the principal investigator based on the photographs of the treated area. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement.
Time frame: Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - patient evaluation.
Improvement in the Global Aesthetic Improvement Scale as evaluated by the patient. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement.
Time frame: Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)
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Visual Analogous Scale (VAS) - principal investigator evaluation.
The absolute change in the Visual Analogous Scale from baseline judged by the principal investigator. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.
Time frame: Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)
Visual Analogous Scale (VAS) - patient evaluation
The absolute change in the Visual Analogous Scale from baseline judged by the patient. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.
Time frame: Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)
Subject satisfaction
The Patient's Questionnaire was utilised. The satisfaction survey grades range from 1 to 3, where grade 1 represents the highest satisfaction level.
Time frame: Session 1 (Day 1), Session 2 (Day 14), Session 3 (Day 60), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Time frame: Session 1 (Day 1), Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)