Split-Face, Randomized, Placebo-Controlled, Double-Blind Study to Investigate Passive Versus Active Dermal Filler Administration

Abstract

Background

QueryHyaluronic acid (HA) is a large polymer increasingly used as dermal filler. HA does not permeate through healthy skin and is administered using various injection techniques. As HA procedures become more popular, the number of complications in facial rejuvenation procedures is likely to increase. Alternative methods may be necessary to satisfy the increasing demand for HA procedures. High-frequency high-intensity ultrasound is a painless and noninvasive method to deliver large molecules to the skin that is expected to deliver HA with visible results.

Objective

Assess facial rejuvenation with HA delivered with high-frequency high-intensity ultrasound.

Methods

Fifteen women (mean age 55) willing to participate in a randomized, double-blind, face-split trial with HA and placebo formulations in different sides of the face, were subject to five treatment sessions with high-frequency high-intensity ultrasound. Photographs taken before the procedure and after the last procedure were evaluated by a panel of five experts, blind to which side was treated with the HA or with the placebo.

Results

The expert panel identified a noticeable facial rejuvenation in the HA side relative to the placebo with a very statistically significant difference between the two sides (p < 0.0001).

Conclusions

Administration of HA with high-frequency high-intensity ultrasound is safe and leads to unambiguous facial rejuvenation.

Level of Evidence I

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