Efficacy and Tolerability of a Topical Peptide-Hyaluronic Acid Lip Treatment Using a Novel Delivery System in Subjects With and Without Prior Lip Augmentation

Abstract

Background: Lips are prone to dehydration and aging. Effective noninvasive hyaluronic acid (HA) delivery remains challenging.

Aim: To evaluate topical Replenishing Lip Filler-Tiered Release Vesicles (RLF-TRV) in filler-naïve and previously-augmented lips.

Methods: Two single-center trials evaluated efficacy and tolerability of RLF-TRV Serum. Study 1 included filler-naïve subjects or those without lip filler for 12 months. Study 2 enrolled subjects with prior HA lip augmentation (3-9 months earlier) in a double-blind, placebo-controlled design. Participants applied RLF-TRV or placebo twice daily for 3 weeks, followed by a 2-week regression period. Outcomes included grading of shine, texture, and vermilion border, Investigator and Subject Global Aesthetic Improvement Scale (I-GAIS, S-GAIS), and satisfaction. Imaging and tolerability assessments were conducted throughout the study.

Results: RLF-TRV significantly improved lip aesthetics (shine, texture, and vermilion border), with high satisfaction across both studies. In Study 1, 94% of treated participants were "Improved" on I-GAIS (p < 0.001), and 81% were "Much-Improved" on S-GAIS (p < 0.05). In Study 2, 88% of treated participants were "Improved" on both I-GAIS and S-GAIS. RLF-TRV was well tolerated, with no recorded adverse events.

Conclusions: RLF-TRV significantly improved lip aesthetics, offering a noninvasive alternative or complementary treatment to injectable procedures.

FIGURE 1

Photonumeric Lip Health Scale ratings for shine (A), texture (B), and vermilion border (C) for Study 1 participants (pink) and Study 2 participants (blue) treated with RLF‐TRV Serum. A lower score indicates improvement. *Statistically significant improvement (p < 0.05). **Statistically significant improvement (p < 0.001) both compared to baseline.

FIGURE 2

Representative results using RLF‐TRV Serum. A 26‐year‐old filler‐naïve subject is shown at baseline (A) and 15‐min post‐application at Week 1 (B) and Week 3 (C). No lip gloss or lipstick was applied to the subject's lips at the time of photography.

FIGURE 3

Representative results using RLF‐TRV Serum. A 49‐year‐old subject is shown at baseline, 8 months after injection with HA filler (A) and at Week 3 (B) after using RLF‐TRV Serum twice daily. No lip gloss or lipstick was applied to the subject's lips at the time of photography.

FIGURE 4

A 24‐year‐old female patient at baseline (A, C) and 2 weeks following daily treatment with RLF‐TRV Serum (B, D). Lip volume increased 0.61 cc from baseline (B), the top lip increased from 7.21 to 7.40 mm, and the bottom lip increased from 9.12 to 10.34 mm. No lip gloss or lipstick was applied to the patient's lips at the time of photography.

FIGURE 5

A 22‐year‐old female patient at baseline (A, C) and 1 week following daily treatment with RLF‐TRV Serum (B, D). Lip volume increased 0.51 cc from baseline, the top lip increased from 8.27 to 8.53 mm, and the bottom lip increased from 9.24 to 10.51 mm. No lip gloss or lipstick was applied to the patient's lips at the time of photography.

FIGURE 6

Percentage of subjects with improvement on the Global Aesthetic Improvement Scale as assessed by the principal investigator (I‐GAIS) and subject self‐assessment (S‐GAIS), for Study 1 participants and Study 2 participants treated with RLF‐TRV serum. *Statistically significant higher proportion of “Much Improved” compared to baseline (p < 0.05); **Statistically higher proportion of “Improved” compared to baseline (p < 0.001).