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

mildly abnormal in 5.4% of patients in the test device group and 3.2% in the comparator group prior to injection at day 1. At subsequent visits, 4.1% to 11.1% in the test device group and 0% to 8.6% in the comparator group had abnormal lip symmetry that was generally mild.

Ease of Use
On a numeric scale from 0 = not easy to 10 = most easy, the median rating for each treatment group in the AT population at both day 1 and day 28 was 8.00; the range was 0 to 10 in the test device group and 6 to 10 in the comparator group.

DISCUSSION

The results of the current study demonstrate the durability of the augmentation provided by the test device and its non-inferiority to the comparator device. The data from the GAIS scoring, on which patients and physicians noted significant differences from baseline at all time points, shows the persistence of clinical effects.

The primary efficacy endpoint was change from baseline to day 56 in overall LFGS of both lips together. If the lower limit of the 95% CI for treatment difference in means (test device minus comparator) was on or above 0.50, the null hypothesis was to be rejected to support the claim that the test device is non inferior to comparator. This was achieved with a 95% CI of ( 0.33) for the definitive analysis in the PP population and was supported by the results (-0.26) for the mITT population. Both treatments showed high rates of treatment success across the secondary and other efficacy endpoints, as well as high rates of patient satisfaction with their lips.

The test device was well tolerated and the AE profiles of the two devices were similar. As expected, injection-site TEAEs were the most frequent AEs. Most were anticipated, mild or moderate in severity, resolved promptly. No persistent nodules, masses, or significant asymmetry were noted during the study. Treatment due to injection-site TEAEs was interrupted in only 1 patient and no patient discontinued the study due to a TEAE.

The success of the test device may be attributed to the manufacturing process which includes an advanced crosslinking process (thixofix) that promotes links between different HA polymer chains and minimizes less effective links on parts of the same chain. The resulting level of crosslinking inhibits natural degradation of filler which prolongs longevity in the treated area. The thixofix process may also minimize elongation of the upper lip over time due to edema.6

The strengths of the present study include the large number of patients, the use of three populations for comparisons, and the comprehensive evaluation of lip function after treatment with both devices. The encouraging results warrant additional studies to further evaluate the clinical benefits achievable by the test device.

CONCLUSION

For lip augmentation, the efficacy and safety of the test device is non-inferior to comparator.

DISCLOSURES

Dr. Smith is a consultant to Prollenium Medical Technologies, Inc. The other authors have no conflicts of interest to disclose.

REFERENCES

1. Beer K, Glogau RG, Dover JS, et al. A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides. Dermatol Surg. 2015;41(Suppl 1):S127–S136.
2. Brody-Camp S, Raggio BS. Lip Implants. 2020 Jun 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–.
3. Gold MH, Baumann LS, Clark CP III, Schlessinger J. A multicenter, doubleblinded, randomized, split-face study of the safety and efficacy of a novel hyaluronic acid gel for the correction of nasolabial folds. J Drugs Dermatol. 2018;17(1):66-73.
4. Carruthers A, Carruthers J, Hardas B, et al. A validated lip fullness grading scale. Dermatol Surg. 2008;34(Suppl 2): S161-S166.
5. Cohen JL, Thomas J, Paradkar D, et al. An interrater and intrarater reliability study of 3 photographic scales for the classification of perioral aesthetic figures. Dermatol Surg. 2014;40:663-670.
6. Woodward J, Ranjit-Reeves R, Katz DF, et al. Comparing water absorption of Food and Drug Administration-approved hyaluronic acid fillers. Dermatol Surg. 2021;47(9):1237-1242.

AUTHOR CORRESPONDENCE

Stacy R. Smith MD srs@cdcrinstitute.com