Evaluation of the Safety and Performance Characteristics of Mesofiller Mesotox for the Correction of Wrinkles and Rehydration of the Face.
NCT Number: NCT06477432
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Aging|Skin Wrinkling
Interventions: DEVICE: mesofiller® mesotox
Sponsor: Mesoestetic Pharma Group S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-15
Completion Date: 2023-07-05
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 the evaluation of the safety and performance of the product mesofiller® mesotox 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: Lemperle's Scale - principal investigator evaluation, The absolute change in Lemperle's Scale from baseline as evaluated by the investigator based on the photographs of the treated area.

The Lemperle's scale is a six-point photographically based classification (0 means no wrinkles, 5 means very deep wrinkles, redundant folds) of mimetic wrinkles and folds that are graded using reference photographs., Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).|Glogau class - principal investigator evaluation, The absolute change in Glogau class from baseline as evaluated by the investigator based on the photographs of the treated area. Glogau photoaging classification includes grades from Grade/Type I (mild) meaning no wrinkles to Grade/Type IV (severe) meaning only wrinkles., Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180) .|Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation, The absolute change in the Wrinkle Severity Rating Scale from baseline, evaluated by the PI based on photographs of the treated area. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome., Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).|Wrinkle Severity Rating Scale (WSRS) - patient evaluation, The absolute change in the Wrinkle Severity Rating Scale from baseline, evaluated by the patient. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome., Session 1 (Day 1); Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).|Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation, Improvement in the Global Aesthetic Improvement Scale as evaluated by the PI based on the photographs of the treated area. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement., Session 1; Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).|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 1; Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).|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; Session 2 (Day 14); Session 3 (Day 60); and Session 4 (Day 180).|Frequency and severity of AEs, SAEs, ISRs, TEAEs, Session 1 (Day 1); Session 2 (Day 14); and Session 4 (Day 180).