Efficacy and safety of e.p.t.q. hyaluronic acid fillers in the context of aesthetic facial rejuvenation or beautification: a post-market clinical follow-up study.

This study was conducted to assess the efficacy and safety of e.p.t.q. hyaluronic acid (HA) fillers (JETEMA Co., Ltd., Yongin, Korea) in the context of aesthetic facial rejuvenation or beautification. The patients were evaluated for changes in the Wrinkle Severity Rating Scale (WSRS) scores, the Mid-Face Volume Deficit Scale (MFVDS) scores and the Medicis Lip Fullness Scale (MLFS) scores at 24 weeks from baseline and those in the investigator- and patient-assessed Global Aesthetic Improvement Scale (GAIS) scores at 24 weeks from 4 weeks and rates of adverse events (AEs), serious AEs (SAEs) and serious adverse device effects (SADEs). The WSRS, MFVDS and MLFS scores reached the highest level at 4 weeks and showed declines thereafter until 24 weeks. Moreover, there were significant changes in the WSRS, MFVDS and MLFS scores at 24 weeks from baseline (p = 0.0000 for all). The investigator- and patient-assessed GAIS scores reached the highest level at 4 weeks and showed declines thereafter until 24 weeks. Moreover, there were significant changes in the investigator- and patient-assessed GAIS scores at 24 weeks from 4 weeks (p = 0.0000 for both). There were 88 cases of AEs in 24 patients (10.39%; 95% CI 6.77-15.06), three cases of ADEs in two (0.87%; 95% CI 0.11-3.09), no cases of SAEs, SADEs and unexpected SADEs in 0 (0.00%; 95% CI 0.00-1.58) and two cases of unexpected ADEs in one (0.43%; 95% CI 0.01-2.39). In conclusion, e.p.t.q. HA fillers might be considered for aesthetic facial rejuvenation or beautification.