Tear Trough Deformity Refinement by an Innovative Hyaluronic Acid Injectable Filler

Background: The tear trough refers to the anatomical depression extending from the medial canthus obliquely down and out across the cheek. With aging or significant weight loss, there is often a loss of subcutaneous volume and thinning of the overlying skin in this area, resulting in a sunken appearance and shadowing that contributes to a fatigued look. Tear trough deformity is often treated with hyaluronic acid (HA) fillers or surgical interventions (blepharoplasty, fat grafting), but minimally invasive treatments have gained popularity due to fewer side effects. The HA-based dermal fillers, specifically designed for the periorbital region, can be used to restore volume, reduce the depth of the tear trough deformity, and improve the overall contour and brightness of the under-eye area. However, challenges like edema and irregularities persist due to filler quality, which usually concerns professionals. Objectives: To evaluate the efficacy and safety of a novel HA filler (20 mg/mL) using specific cross-linked enhanced dermal integration system-mono-densified sphere creation (SCEDIS-MSCS) technology, which produces monophasic, mono-densified HA Neo-Spheres for enhanced stability, tissue integration, and resistance to degradation compared to traditional non-cross-linked or polydensified HA fillers for tear trough deformity correction in a prospective single-arm pilot trial. Methods: A prospective single-arm study enrolled sixteen Caucasian females (40.5 ± 5.45 years) with Fitzpatrick type III-IV skin and longstanding tear trough deformity. Participants received a single session of HA filler injections (1 mL total, 0.5 mL per side) using a 25 G cannula. Outcomes were assessed using the Global Aesthetic Improvement Scale (GAIS), high-resolution digital photography, and a modified Tear Trough Improvement Scale (TTIS) Questionnaire at baseline, immediately after, and one month post-treatment. Statistical analysis employed one-way Friedman ANOVA and Wilcoxon signed-rank tests with a significance level of α = 0.10. Results: The GAIS scores indicated significant improvement in tear trough appearance (P = 0.05, 18.2% reduction in wrinkle severity, mean ± SD 5.8). The TTIS scores increased from 29.2 ± 4.5 to 41.8 ± 3.9, P = 0.001) one month post-treatment, reflecting high patient satisfaction. Digital photography confirmed visible refinement in infraorbital hollows. No significant adverse events, including prolonged edema, were reported. Conclusions: The SCEDIS-MSCS HA filler significantly improved tear trough deformity with sustained effects at one month, suggesting its potential as an effective non-surgical treatment. A larger randomized controlled trial (RCT) is warranted to confirm efficacy.