Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of Mild and Moderate Facial Wrinkles.
NCT Number: NCT06486740
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Aging|Skin Wrinkling
Interventions: DEVICE: mesofiller aox
Sponsor: Mesoestetic Pharma Group S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-03
Completion Date: 2024-01-08
Locations: "Medical Center Ramus" EOOD, Sofia, 1000, Bulgaria

Summary:
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.

Primary Outcome Measures: Frequency and severity of AEs, SAEs, ISRs, TEAEs, Two months after the first treatment (Session 3 (Day 60))
Secondary Outcome Measures: 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., 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., 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., 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., Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)|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., 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., 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., 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, Session 1 (Day 1), Session 2 (Day 14), Session 4 (Day 180), Session 5 (Day 270), and Session 6 (Day 365)