The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.
This was a monocentric, prospective, randomized, phase II and double-blind study. At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both the whole face and the lower face) were taken. On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml for the right nasolabial fold and 0,5ml for the left nasolabial fold. The sides will be randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices: * In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit; * In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit. Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula.
hyaluronic acid with metallic cannula.
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Centro Brasileiro de Estudos em Dermatologia
Porto Alegre, Brazil
Number of Participants With Haematoma
Number of participants with haematoma at each visit
Time frame: Day 1; day 3; day 7; day 90
Number of Participants With Erythema
Number of participants with erythema at each visit
Time frame: Day 1; day 3; day 7; day 90
Modified Fitzpatrick Wrinkle Scale (MFWS)
Class 0 - No visible wrinkles; continuous skin lines Class 0.5 - Very shallow yet visible wrinkles Class 1 - Fine wrinkles. Visible wrinkles and slight indentations Class 1.5 - Visible wrinkles and clear indentations,\<1-mm wrinkle depth\* Class 2 - Moderate wrinkles. Clearly visible wrinkles, 1- to 2-mm wrinkle depth\* Class 2.5 - Prominent and visible wrinkles; 2- to 3-mm wrinkle depth\* Class 3 - Deep wrinkles. Deep, furrowed wrinkle; \*\>3-mm wrinkle depth
Time frame: Baseline and 90 days
Global Aesthetic Improvement Scale
1. Very much improved: Optimal cosmetic result for the implant in this patient 2. Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition
Time frame: 90 days
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