Adele Sparavigna 1, Beatrice Tenconi 1, Laura La Penna 1
1 DERMING S.r.l., Milano, Italy.
Aesthetic Medicine / Volume 4 / Nº 4 / October – December 2018
Background: Hyaluronic acid (HA) is commonly used in aesthetic medicine, often mixed with lidocaine to reduce injection discomfort/pain. However, this approach still raises some concerns relating to the possible impairment of quality and efficacy, and possible allergic reactions.
Aim: This study compared Aliaxin EV, a HA-based filler, with and without lidocaine, in terms of efficacy discomfort/
Methods: Aliaxin EV with and without 0.3% lidocaine were compared in this single blind, single-center study by split-face method. Twenty-six female volunteers aged 40-65 were treated. Study treatments included one baseline visit with product injection, and a final visit after 4 weeks. Efficacy evaluations included WSRS and GAIS scales and skin profilometry by 3D nasolabial fold pictures. Tolerability was clinically assessed by the investigator and rated by volunteers on separate
VAS for stinging, itching, tightening, burning, discomfort and pain.
Results: Both preparations induced a very significant reduction in wrinkles severity (WSRS score: -33.3%, p<0.001 for both preparations). Aesthetic performance was rated as improved compared to baseline according to the GAIS for all 52 hemifaces. Skin profilometry demonstrated statistically significant reductions versus baseline in average roughness (-36% without and -32% with lidocaine; both p<0,001 vs baseline) and wrinkle maximum depth (-41% and -31%; p<0,001). Immediately after the injection procedure the differences in VAS for pain/discomfort sensations were significant, but not significant at the 2-hour assessment. Only 3 subjects scored a VAS >5.
Conclusions: Aliaxin EV was effective in reducing nasolabial folds, giving a satisfying aesthetic performance with very
well tolerated results, both with and without the addition of lidocaine.