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 mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
The product mIntense L+AS is a dermal filler manufactured by mesoestetic Pharma Group s.l. It was intended to be used as a temporary filler to correct small skin defects, such as wrinkles or scars. In particular, it was recommended for the treatment of deep wrinkles. mIntense L+AS for the facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product containing cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation. This clinical investigation was conducted as an uncontrolled - no comparator was used. The safety and performance of the treatment were 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 mIntense L+AS 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. Both sessions were conducted within 14-day intervals. The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The investigated dermal filler mIntense L+AS is intended to be used as a temporary filler, administered by intradermal or subcutaneous injections, to correct small skin defects, such as wrinkles or scars.
"Medical Center Ramus" EOOD
Sofia, Bulgaria
Frequency and severity of AEs, SAEs, ISRs, TEAEs
The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature
Time frame: Two months after the first treatment (Session 3 (Day 60))
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: Session 2 (Day 14); Session 3 (Day 60); 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 PI. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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
The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature
Time frame: Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)