Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Feb;44(2):261-269.
doi: 10.1097/DSS.0000000000001282.

Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement

Said Hilton  1 , Gerhard Sattler  2 , Anna-Karin Berg  3 , Ulf Samuelson  4 , Cindy Wong  5
Affiliations
Randomized Controlled Trial

Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement

Said Hilton et al. Dermatol Surg. 2018 Feb.

Abstract

Background: Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect.

Objective: To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement.

Materials and methods: Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product.

Results: A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated.

Conclusion: Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

PubMed Disclaimer

Conflict of interest statement

Supported by Galderma. S. Hilton is a consultant for Allergan, Galderma, Q-Med, S&V Technologies, Cosmetique, L'Oreal, Sanofi-Aventis, and HAL. G. Sattler has lectured for and serves on the advisory board for Allergan, Galderma, and Merz. U. Samuelson has lectured for Allergan, Galderma, and Novus Scientific and serves on the advisory board for Eternogen. C. Wong is an employee for Galderma. Medical Writing Assistance was provided by PCG Clinical Services. The remaining author has indicated no significant interest with commercial supporters.

Figures

Figure 1.
Figure 1.
Disposition of subjects.
Figure 2.
Figure 2.
Proportions of subjects with improvement in Global Aesthetic Improvement Scale in both upper and lower lips assessed by treating investigators, blinded evaluators, and subjects, intention-to-treat population. No statistically significant differences between groups at any time point, Fisher exact test.
Figure 5.
Figure 5.
Photographs of lips from 1 subject treated with HA-RK at baseline (A) and 12 months after treatment (B). HA, hyaluronic acid.
Figure 3.
Figure 3.
Proportions of subjects with ≥1 grade improvement in Lip Fullness Grading Scale in both lips by treating investigators and blinded evaluators, intention-to-treat population. No statistically significant differences between groups at any time point, Fisher exact test.
Figure 4.
Figure 4.
Responses to the subject satisfaction questionnaire on satisfaction, attractiveness, natural looking lips, and adding balance to facial features, intention-to-treat population. Total number of subjects responding to the questionnaire in the HA-RK/HA-JV groups at Month 1: N = 28/N = 29; Month 12: N = 25/N = 22. HA, hyaluronic acid.
See this image and copyright information in PMC

References

    1. Penna V, Stark GB, Eisenhardt SU, Bannasch H, et al. The aging lip: a comparative histological analysis of age-related changes in the upper lip complex. Plast Reconstr Surg 2009;124:624–8. - PubMed
    1. Monheit GD, Coleman KM. Hyaluronic acid fillers. Dermatol 2006;19:141–50. - PubMed
    1. Carruthers A, Carruthers J, Hardas B, Kaur M, et al. A validated lip fullness grading scale. Dermatol Surg 2008;34(Suppl 2):S161–6. - PubMed
    1. Dayan S, Bruce S, Kilmer S, Dover JS, et al. Safety and effectiveness of the hyaluronic acid filler, HYC-24L, for lip and perioral augmentation. Dermatol Surg 2015;41(Suppl 1):S293–301. - PubMed
    1. Raspaldo H, Chantrey J, Belhaouari L, Saleh R, et al. ; for the Juvéderm Volbella Study Group. Juvéderm Volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open 2015;3:e321. - PMC - PubMed

Publication types