The durability, appearance appraisal, effects on quality of life (QOL), and safety among the most frequently used hyaluronic acid dermal fillers in the Netherlands showed overall statistically significant increases from baseline to 13-week follow-up, but no clear single between-product superiority regarding durability, patient satisfaction and QOL. These are among the study results presented in a letter to the editor published in Journal of the American Academy of Dermatology.
Researchers conducted a multicenter, randomized, , parallel, quadruple-blind clinical trial (ClinicalTrials.gov Identifier: NCT043628910) that included 160 adult women who requested lip augmentation. Among this group, 17 failed to present at the first appointment, leaving 143 to be randomly assigned in a 1:1:1:1 ratio to receive 1.2 mL of either hyaluronic acid gel, nonanimal hyaluronic acid gel, hyaluronic acid, or nonanimal hyaluronic acid gel with idocaine and mannitol followed by injection between July 2021 and January 2022.
Among this group, 14 were lost prior to injection, which left 129 participants injected with hyaluronic acid dermal fillers. Among these 129 participants, 39 were lost to follow-up; a total of 90 participants had measurements at the 13-week follow-up.
Researchers found an overall lip height increase from baseline to follow-up of 18.9% (P <.01) in linear mixed model analysis. They noted overall appearance appraisal increase from baseline to follow-up of 40.7% (P <.01). Overall increases were observed from baseline to follow-up in social function (9.8%) and psychological well-being (8.7%, all P <.01).
They noted between-product differences of increases in lip height from baseline to follow-up with nonanimal hyaluronic acid gel with idocaine and mannitol (26.3%) and hyaluronic acid gel (10.9%). The absolute difference between these 2 brands (15.4%) suggested there was a clinically relevant longer duration of nonanimal hyaluronic acid gel with idocaine and mannitol.
There were between-product differences of increases in appearance appraisal with hyaluronic acid gel (50.7%) and nonanimal hyaluronic acid gel (29.8%). The absolute difference between these 2 brands was 20.9%, which suggested a clinically relevant better appraisal of hyaluronic acid gel over time.
There were between-product differences of increases in social function with nonanimal hyaluronic acid gel with idocaine and mannitol (11.0%) and nonanimal hyaluronic acid gel (6.3%). Hyaluronic acid gel had 25.3% higher side effect scores than nonanimal hyaluronic acid gel with idocaine and mannitol.
Limitations of the study include the possibility of response bias, nonresponse bias, loss to follow-up creating selection bias, and underpowered sample sizes.
Study authors conclude, “Statistically significant but clinically arguably relevant superiority was found with regard to duration, patient satisfaction, and QOL.” They found safety profiles to be equal and no product superior in all categories.
Steenen SA, Bauland CG, van der Lei B, et al. Head-to-head comparison of 4 hyaluronic acid dermal fillers for lip augmentation: a multicenter randomized, quadruple-blind, controlled clinical trial. J Am Acad Dermatol. Published online November 9, 2022. doi:10.1016/j.jaad.2022.11.012