Dataset Information

The Role of Clinical Examination in Midface Volume Correction Using Hyaluronic Acid Fillers: Should Patients Be Stratified by Skin Thickness?

ABSTRACT:

Background

Aesthetic physicians have several hundred injectable products to select from. Due to differences in their manufacturing technology, these products display varying biophysical qualities, such as their cohesivity and lift capacity. Currently, there is no guidance to objectively selecting the best product for a particular patient. Therefore, an algorithmic approach is required to take specific skin characteristics into consideration.

Objectives

To evaluate (1) whether subjects seeking injectable treatments for midfacial volume loss and/or contour deficiency can be stratified based on specific skin characteristics (eg, thickness, fat quantity, bony structure) and (2) whether particular hyaluronic acid fillers perform best when used in such particular strata.

Methods

This was a prospective, Phase IV, open-label, single-center clinical trial. Thirty female patients with midface/cheek volume loss and/or contour deficiency were recruited (mean age, 53.5 years; SD, 12.57; range, 35-75 years). Subjects were treated with either Restylane Lyft (HA_L) or Restylane Volyme (HA_V) and followed for 4 months post-injection. Treatment allocation was based on the treating physician's clinical evaluation and compared with ultrasound evaluation. Ultrasound images were used to confirm stratification. Safety and efficacy assessments were performed at each study visit: baseline, week 2, week 4, week 8, and week 16. Subgroup analyses evaluated whether particular strata performed best when treated with specific products.

Results

The 2 investigative products varied in their efficacy, depending on the characteristics of the subject.

Conclusions

The use of a treatment algorithm may improve outcomes for patients seeking injectable treatments for midfacial volume loss and contour deficiencies.

Level of evidence 2

SUBMITTER: Nikolis A

PROVIDER: S-EPMC7671260 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundHyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects.MethodsSubjects received treatment with Juvéderm(™) Voluma(™) to the malar area, based on the investigators' determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS).ResultsOf the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma(™) at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma(™), with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported.ConclusionVoluma(™) is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.