Efficacy and Performance Evaluation of mGlobal L+AS 20 mg/ml Hyaluronic Acid, for the Correction of Light to Moderate Wrinkles and Folds
NCT Number: NCT06482723
Acronym: M-GLO-LS
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Aging|Skin Wrinkling
Interventions: DEVICE: mGlobal L+AS
Sponsor: Mesoestetic Pharma Group S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-03
Completion Date: 2023-08-03
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 the safety and performance of the product mGlobal L+AS for correction of small skin defects, such as wrinkles or scars, in particular for the treatment of wrinkles around the lips 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, The safety evaluation of mGlobal L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature, Two months after the first treatment (Session 3 (Day 60))
Secondary Outcome Measures: Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation, The absolute change in Wrinkle Severity Rating Scale from baseline, evaluated by the PI, based on the photographs of the treated area. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome., Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)|Wrinkle Severity Rating Scale (WSRS) - patient evaluation, The absolute change in 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 2 (Day 14); Session 3 (Day 60); 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 PI 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 3 (Day 60); 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 3 (Day 60); 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 PI. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome., Session 2 (Day 14); Session 3 (Day 60); 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 3 (Day 60); 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., Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)|Frequency and severity of AEs, SAEs, ISRs, TEAEs, Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)