Safety and Effectiveness of a Novel Hyaluronic Acid Gel for Lip Augmentation

January 2022 | Volume 21 | Issue 1 | Original Article | 13 | Copyright © January 2022


Published online December 30, 2021

Jeffrey Adelglass MD,a Javier Alonso-Llamazares MD PhD,b Jeremy Fenton MD,c Michael H. Gold MD,d Joel Schlessinger MD,e Stacy R. Smith MDf

aSkintastic, Plano, TX
bInternational Dermatology Research, Inc. Miami, FL
cSchweiger Dermatology, PLLC New York, NY
dTennessee Clinical Research Center, Nashville, TN
eSkin Specialists, PC, Omaha, NE
fCalifornia Dermatology & Clinical Research Institute Encinitas, CA



75% for test device and comparator, respectively. On day 168 the proportions improved, much improved, or very much improved were 100% for the test device and 76% for comparator). The results for each category (improved, much improved, very much improved) are shown in Figures 6 through 8.

Swelling
For the PP population, minimal swelling was reported on day 28 for 4 (7.4%) patients with test device and on 1 (1.8%) patient with comparator. On day 56 the only subsequent swelling was minimal for 1 patient with comparator.

Upper and Lower Lips Separately
The percent of patients with treatment success at day 56 (where success was defined as achieving a ≥1-grade increase from baseline on the LFGS) was 94.4% with test device and 89.1% with comparator for the upper lips, and 92.6% with test device and 87.3% with comparator for the lower lips.

On day 84, the percent of responders on the POL severity scale (responder defined as a patient with a ≥ 1-point improvement [decrease in severity] from baseline), was 66.7% with test device and 61.9% with comparator for the upper lips, and 47.6% with test device and 42.9% with comparator for the lower lips.

Satisfaction
Mean Patient Satisfaction with Lips on the visual analog scale at each scheduled visit ranged from 76.3 to 84.4 in the test device group and from 72.8 to 86.3 in the comparator group. The mean rating was highest on day 84 in the test device group (84.4) and on day 56 in the comparator group (86.3).

Safety
For the AT population, the AE profile was similar between the treatment groups. Most patients (93.8% test device, 96.2% comparator) had TEAEs (excluding vascular injections/visual events) with the most frequent being injection site swelling, injection site bruising, injection site pain, and facial asymmetry (Figure 9). Most TEAEs were reported as mild or moderate in intensity.

Two patients in each treatment group had AEs of special interest that involved vascular injections/visual events, which were not related to treatment. One serious AE was reported, breast cancer stage II. Two of the AEs of special interest, retinal detachment (test device) and facial paralysis (Bell’s palsy, comparator), were originally reported as AEs and subsequently elevated to serious AEs.

No patient discontinued the study due to a TEAE. One patient in the test device group had treatment interrupted/discontinued due to injection-site TEAEs, which were treated and resolved, and the patient completed the study. One patient discontinued the study due to pregnancy.

Regarding lip function and sensation, all patients were able to sip liquid through a straw, feel sensation of a 0.4G monofilament, and feel sensation of a cotton wisp at all visits. All except 2 patients (1 in each group) had normal lip texture and all except 1 patient (test device) had normal lip firmness as at all visits.

Their ability to pucker lips, blow with lips, and pronounce words that began with “W” were also normal. Lip symmetry was