Efficacy Evaluation of a Hyaluronic Acid Dermal Filler Containing Mannitol: Clinical and Aesthetic Assessment Using High-Frequency Ultrasound.

ABSTRACT

BACKGROUND: Mannitol may be a good excipient for hyaluronic acid (HA) filler. OBJECTIVE: This study aimed to assess the tolerability and effectiveness of a mannitol-containing HA filler for the improvement of nasolabial folds (NLFs). PATIENTS AND METHODS: Thirty Middle Eastern participants aged 18 to 65 years with moderate-to-severe NLFs on the Wrinkle Severity Rating Scale (WSRS) received 1 to 2 mL of a HA filler containing mannitol in both NLFs. Wrinkle Severity Rating Scale; volume, depth, and area of NLFs; and ultrasound parameters were measured at baseline, Weeks 2, 12, and 24 after the injection. Adverse events and participants' satisfaction were recorded in all follow-up visits. RESULTS: Eighty-nine percent, 86%, and 61% of participants showed at least one grade improvement in WSRS, at Weeks 2, 12, and 24, respectively. The area and volume of NLFs significantly decreased compared with baseline (p-value < .01). In severe NLFs, echo density of the dermis significantly increased at Week 2. Participants reported great satisfaction with the treatment, and adverse events were mainly mild and transient. One patient had significant pain during injection, but this resolved without sequelae. CONCLUSION: The tested mannitol-containing HA filler showed to be effective in Middle Eastern participants. The safety will require a follow-up larger study.