Prospective Clinical Evaluation of Cross-Linked Hyaluronic Acid Dermal Filler (30 mg) for Facial Rejuvenation

Abstract

Background:

Cross-linked hyaluronic acid dermal fillers are being used increasingly for aesthetic enhancements, including lip enhancement, cheekbone augmentation, and nasolabial fold improvement. This study aimed to assess the safety and performance of a newly introduced dermal filler across different skin types.

Methods:

This is a prospective, single-arm clinical study that evaluates the safety and effectiveness of cross-linked sodium hyaluronate injection in patients undergoing treatment for facial wrinkles and lip enhancement. Participants underwent assessments at baseline; immediately at postoperative day 0; and at 3 months, 6 months, and 1 year after the procedure. The safety and effectiveness were evaluated through physical examinations, wrinkle severity ratings, full face global aesthetic assessments, cheekbone augmentation, nasolabial fold severity, and lip enhancement evaluations.

Results:

The study cohort included 122 participants, 41 men and 81 women, predominantly with Fitzpatrick skin types 3 (59%) and 4 (41%). Physical examinations revealed a significant reduction in facial wrinkles, with 81.14% (left side) and 84.42% (right side) of patients showing no wrinkles after 1 year. Full face aesthetic improvements were noted, with 36.88% of patients being “very much improved.” Cheekbone augmentation showed no wrinkles in 55.74% of patients (left side) and 72.13% (right side) at 1 year. Nasolabial fold severity decreased most significantly between 6 months and 1 year.

Conclusions:

The novel cross-linked hyaluronic acid dermal filler is safe and effective for enhancing lips, augmenting cheekbones, and improving nasolabial folds across various skin types. Significant improvements were observed in wrinkle severity, overall facial aesthetics, and specific enhancement areas.

Takeaways

Question: This study evaluated the safety and efficacy of the new 30-L cross-linked hyaluronic acid filler for lips, cheekbones, and nasolabial folds across diverse skin types.

Findings: This single-arm study of 122 participants (mainly Fitzpatrick types 3 and 4) showed significant improvements in wrinkles, facial aesthetics, cheekbones, and lips with no filler-related adverse events. Follow-up (1 y) reported safety and efficacy.

Meaning: The study confirms that 30-L cross-linked hyaluronic acid filler is safe and effective for reducing wrinkles and enhancing lips and cheekbones, with no safety concerns.

INTRODUCTION

The perception of beauty involves societal norms, personal interactions, and self-perception, highlighting the complex link between appearances and their interpretations, making facial aesthetic procedures highly relevant.^1,2 Facial aging is a complex biological phenomenon influenced by a combination of intrinsic and extrinsic factors. Intrinsic aging is primarily driven by genetic predispositions and the natural physiological processes that occur within the body over time.³ This includes the gradual degradation of collagen and elastin fibers in the dermis, which leads to a decrease in skin elasticity and firmness.⁴ Structural changes in facial anatomy contribute to the visible signs of aging, including loss of facial fat compartments, bone resorption, and changes in muscle tone. These alterations result in a loss of volume in specific facial regions, such as the cheeks and temples, and lead to sagging of soft tissues.⁵ In the Indian face, aging commonly manifests as crow’s feet at an early age of 35–40 years, tear trough deformity, nasolabial folds (NLFs), marionette lines, and loss of fullness in the buccal pad.⁶ This implies that the lower two-thirds of the Indian face ages faster as compared with the upper one-third.⁷ Over the years, emergence of minimally invasive, injectable, implant-based facial enhancement as a viable alternative to reconstructive surgery has revolutionized aesthetics.⁸

Hyaluronic acid (HA) dermal fillers have become a popular choice for minimally invasive facial aesthetic treatments due to their ability to restore volume, improve facial contours, and enhance specific areas without the need for surgery. In particular, HA-based fillers offer a noninvasive solution for cheekbone augmentation, NLF improvement, and lip enhancement. By providing a nature-based and well-tolerated solution, these fillers elaborate potential to address the volume loss and soft tissue sagging associated with facial aging, particularly in areas such as the cheeks and lips, which are prone to early signs of aging.⁹ HA-based implants have been the most widely used fillers and have gained acceptance primarily because of the high biocompatibility of HA over and above other substances.⁹ Owing to its capacity to retain moisture and its ease of application, this substance offers a viable, nonsurgical option for addressing facial contour irregularities. HA dermal fillers are also safe and effective.¹⁰ The widespread acceptance of HA fillers demonstrates their biocompatibility, the stability of cross-linked HA in vivo, and their strong record of safety and effectiveness in other countries where they have been used for many years.¹¹

Technological advances continue in the design of injectable dermal implants. A new HA-based dermal filler implant has recently become available that uses a new technology of molecular engineering and consists of cross-linked HA formulated to a concentration of 30 mg/mL suspended in a physiological buffer.¹² Hence, this study was conducted to assess the safety, efficacy, and performance of a cross-linked HA dermal filler in patients undergoing cheek bone augmentation, NLF improvement, and lip enhancement of the face for treatment.

MATERIALS AND METHODS

The study follows the design of a prospective, single-arm, clinical study to assess the safety and performance of a cross-linked HA dermal filler. The clinical investigation was performed in accordance with International Council for Harmonisation Good Clinical Practice guidelines, International Organization for Standardization 14155 guidelines, and the Declaration of Helsinki 1–4. The study was registered with the Clinical Trial Registry of India (CIP Identification: CTRI/2021/12/039025). The medical device under study consisted of cross-linked HA formulated to a concentration of 30 mg/mL suspended in a physiological buffer (brand name and generic name: JO 30-L [0.5 mL/0.8 mL/1.0 mL] cross-linked sodium hyaluronate solution 3% wt/vol [manufactured by Biotech Vision Care Pvt. Ltd.]).

Inclusion Criteria

The patients included were in the age group between 18 years or older and 75 years or younger, seeking soft tissue augmentation treatment on the face. The patients agreed to follow-up examinations up to 6 months after final treatment and had a pretreatment Wrinkle Severity Rating Scale (WSRS) score of 2 or greater for bilateral NLF to be treated.

Exclusion Criteria

Patients were excluded if they had previous permanent filler injections in the treatment area, were pregnant or lactating, or had allergies to lidocaine, prilocaine, or other amide anesthetics. Other exclusions included recent chemical peels at the NLF (within 4 wk), ongoing Botox treatments, history of skin pigmentation disorders, infections, wounds, keloids, bleeding disorders, leukoderma or a family history of pigmentary disorders, or use of blood thinners. Patients with severe physical, neurological, or mental illnesses or excessive facial hair interfering with wrinkle assessment were also excluded.

Recruitment Process

Participants were recruited through advertisements and referrals, followed by a structured screening process, medical history review, physical examination, and diagnostic tests to confirm eligibility based on inclusion and exclusion criteria. Baseline assessments, including wrinkle severity scoring and NLF photography, were conducted before enrollment, ensuring compliance with study requirements for follow-ups and evaluations.

The Treatment and Treatment Allocation Schedule

Injections were performed at baseline, with no corrective injections allowed during the study. Each patient received injections in the lips, NLF (with or without marionette line), both zones together, or cheekbones. Volume and technique were at the injector’s discretion. The study lasted approximately 12 months, including day 0, 3-month, 6-month, and 12-month follow-ups.

Assessments and Outcomes

Patients were followed up for 12 months and evaluated using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale rating aesthetic improvement compared with pretreatment. Categories include “worse,” “no change,” “improved,” “much improved,” and “very much improved.” GAIS was measured at baseline and follow-up, with results compared with those at baseline. Responder rates were assessed for cheekbone, NLF, and lip improvements. Enhancement from day 0 to 3, 6, and 12 months is presented using frequency and percentage.

The WSRS is a 5-point tool used to objectively assess facial wrinkle severity. The WSRS uses a 5-point scale to rate wrinkle severity: absent (0), very mild (1), mild (2), moderate (3), and severe (4). In this study, it evaluated the effectiveness of cross-linked HA fillers for lip enhancement, cheekbone augmentation, and NLF improvement at baseline, at postoperative day 0, and at 3 months, 6 months, and 1 year after the procedure.

The Lemperle Rating Scale, ranging from 0 (no wrinkles) to 5 (very deep wrinkles), assessed NLF severity. Baseline and follow-up scores were compared with measure treatment efficacy, with reductions indicating clinical improvement. The GAIS, WSRS, and Lemperle scales were selected for their complementary ability to provide a comprehensive assessment of aesthetic outcomes following the use of HA dermal fillers.

Odds Ratio Calculation

To evaluate changes in NLF severity, odds and odds ratios (ORs) were calculated for participants classified as having “just perceptible wrinkles.” The odds at baseline were calculated using the following formula:

$${\displaystyle \begin{array}{l}{\displaystyle \mathrm{O}\mathrm{d}\mathrm{d}\mathrm{s}\mathrm{a}\mathrm{t}\mathrm{b}\mathrm{a}\mathrm{s}\mathrm{e}\mathrm{l}\mathrm{i}\mathrm{n}\mathrm{e}=\frac{p^b}{(1-p^b)},}\end{array}}$$

where p^b is probability at the baseline.

The odds at 6 months after the treatment were calculated as follows:

$${\displaystyle \begin{array}{l}{\displaystyle \mathrm{O}\mathrm{d}\mathrm{d}\mathrm{s}\mathrm{a}\mathrm{t}6\mathrm{m}\mathrm{o}\mathrm{n}\mathrm{t}\mathrm{h}\mathrm{s}=\frac{p^6}{(1-p^6)},}\end{array}}$$

where p⁶ is probability at 6 months.

The overall OR was then determined by

$${\displaystyle \begin{array}{l}{\displaystyle \mathrm{O}\mathrm{R}=\frac{\mathrm{O}\mathrm{d}\mathrm{d}\mathrm{s}\mathrm{a}\mathrm{t}6\mathrm{m}\mathrm{o}\mathrm{n}\mathrm{t}\mathrm{h}\mathrm{s}}{\mathrm{O}\mathrm{d}\mathrm{d}\mathrm{s}\mathrm{a}\mathrm{t}\mathrm{b}\mathrm{a}\mathrm{s}\mathrm{e}\mathrm{l}\mathrm{i}\mathrm{n}\mathrm{e}}\mathrm{o}\mathrm{r}\frac{p^b}{(1-p^b)}÷\frac{p^6}{(1-p^6)}.}\end{array}}$$

An OR greater than 1 was interpreted as an improvement in nasolabial fold severity over time, indicating that patients were more likely to achieve just perceptible wrinkles at 6 months compared to baseline.

Statistical Design and Analysis

The sample size was based on detecting a 10% improvement in the GAIS responder rate across lip enhancement, cheekbone augmentation, and NLF correction, requiring 97 patients for 80% power at a 5% significance level. To account for a 20% dropout rate, 122 participants were enrolled.

Data were entered in Microsoft Excel (2020)¹³ and analyzed using Statistical Package for the Social Sciences, version 25.0.¹⁴ Descriptive statistics were expressed as frequencies and percentages. One-way repeated measures analysis of variance with Bonferroni post hoc tests compared facial assessment parameters across visits. Spearman’s rank correlation examined relationships between patient characteristics and outcomes. Significance was set at a P value of 0.05 or less.

RESULTS

A total of 176 patients were screened; 54 patients were excluded after final screening due to minor discrepancies regarding their respective medical histories and slight variations in health conditions that could affect the study’s outcomes, despite not directly violating the primary exclusion criteria. Eventually, 122 patients were successfully enrolled in the study, all of whom completed the entire research duration. None of the patients discontinued participation prematurely. The screening and enrollment process is depicted in Figure 1.

Fig. 1.

Participants’ screening and enrollment process.

Demographic Details

A total of 122 patients participated in the study, out of which 41 were men and 81 were women. Demographic details of the participants are depicted in Table 1.

Table 1.

Demographic Characteristics of the Patients Enrolled in This Study

Characteristics	n (%)
Gender
Male	41 (33.6)
Female	81 (66.4)
Age, y
20–30	42 (34)
31–40	27 (22)
41–50	16 (13)
51–60	37 (30)
Fitzpatrick skin photograph type
Type 1	0
Type 2	0
Type 3	72 (59)
Type 4	50 (41)
Type 5	0
Type 6	0

Physical Examination of the Face

Physical examination of the face was done by assessing the scars on the face, symmetrical line, pimples, rashes, and hives at baseline; immediately at follow-up postoperative day 0 (F1); and at 3 months (F2), 6 months (F3), and 1 year (F4). The findings of the physical examination of the face have been summarized in Table 2.

Table 2.

Physical Examination of the Face

	Left, n (%)					Right, n (%)
	Baseline	F1	F2	F3	F4	Baseline	F1	F2	F3	F4
No scars on the face	46 (37.70)	40 (32.79)	42 (32.43)	39 (31.97)	42 (34.43)	53 (43.44)	50 (40.98)	54 (44.26)	53 (43.44)	55 (45.08)
Symmetrical line	67 (54.92)	74 (60.65)	72 (59.02)	78 (63.93)	73 (59.84)	65 (53.28)	68 (55.74)	65 (53.28)	69 (56.56)	66 (54.10)
Pimples	9 (7.38)	8 (6.56)	8 (6.56)	5 (4.10)	7 (5.74)	4 (3.28)	4 (3.28)	3 (2.46)	0	1 (0.82)
Rashes	0	0	0	0	0	0	0	0	0	0
Hives	0	0	0	0	0	0	0	0	0	0
F	163.322					178.838
P	0.945					0.466

Severity of Wrinkles

Wrinkle severity was assessed using the WSRS at baseline; immediately at postoperative day 0; and at 3 months, 6 months, and 1 year on both sides of the face (Table 3). Creases were significantly reduced in 72.95% of the patients on the right side at 3 and 6 months and in 84.42% of the patients on the left side at 1 year. Statistically significant improvements were observed (P = 0.024* for the left side; P < 0.001** for the right side; both "*" and "**" indicate P < 0.05, signifying that the results are statistically significant). Bonferroni post hoc test confirmed significant improvements at each follow-up (P < 0.05). These findings reflect a visible reduction in wrinkles, smoother skin texture, and increased volume. There are 3 main reasons for the wrinkle reduction and facial volumization.

Table 3.

Wrinkle Severity Rating Scale

	Left, n (%)					Right, n (%)
	Baseline	F1	F2	F3	F4	Baseline	F1	F2	F3	F4
Absent	6 (4.91)	28 (22.95)	91 (74.59)	94 (77.04)	99 (81.14)	9 (7.37)	33 (27.04)	89 (72.95)	105 (86.06)	103 (84.42)
Mild	24 (19.67)	73 (59.83)	21 (17.21)	26 (21.31)	18 (14.75)	27 (22.13)	60 (49.18)	23 (18.85)	17 (13.93)	19 (15.57)
Moderate	57 (46.72)	14 (11.47)	6 (4.91)	4 (3.27)	5 (4.09)	53 (43.44)	19 (15.57)	9 (7.37)	0	0
Severe	35 (28.68)	7 (5.73)	4 (3.27)	0	0	38 (31.14)	10 (8.19)	1 (0.81)	0	0
Extreme	0	0	0	0	0	1 (0.81)	0	0	0	0
F	608.314					1662.964
P	0.024*					<0.001**

Wrinkle Reduction (Peaks at 6 Months)

Collagen stimulation

HA showed stimulation of collagen production, which peaked around 6 months, leading to optimal wrinkle reduction.

Firming and smoothing

By 6 months, collagen remodeling maximized the reduction in wrinkles, giving the best results.

Facial Volumization (Peaks at 12 Months)

Gradual breakdown

Tissue integration continued despite breakdown of HA fillers, supporting volume even as the filler degrades. Water retention and ongoing tissue remodeling help the face retain fullness, leading to peak volumization at 12 months.

Full Face Global Aesthetic Assessment

The Full Face Global Aesthetic Assessment showed significant improvement after 1 year: 36.88% of patients were “very much improved,” 48.36% were “much improved,” 13.11% were “improved,” and 1.64% showed “no change” (P < 0.001) (Table 4). Bonferroni post hoc test confirmed significant differences in full face global aesthetic at each session (P < 0.05).

Table 4.

Full Face Global Aesthetic Assessment

	Left, n (%)					Right, n (%)
	Baseline	F1	F2	F3	F4	Baseline	F1	F2	F3	F4
Very much improved	0	16 (13.11)	18 (14.75)	42 (34.42)	45 (36.88)	0	5 (4.10)	18 (14.75)	42 (34.42)	45 (36.88)
Much improved	0	51 (41.80)	74 (60.6)	52 (42.62)	59 (48.36)	0	47 (38.52)	74 (60.6)	52 (42.62)	59 (48.36)
Improved	0	23 (18.85)	9 (7.38)	15 (12.30)	16 (13.11)	0	39 (31.97)	9 (7.38)	15 (12.30)	16 (13.11)
No change	24 (19.6)	17 (13.93)	17 (13.93)	13 (10.66)	2 (1.64)	34 (27.86)	21 (17.21)	20 (16.39)	13 (10.66)	2 (1.64)
Worse	83 (68.03)	11 (9.01)	4 (3.27)	0	0	65 (53.28)	8 (6.55)	1 (0.82)	0	0
Much worse	12 (9.83)	4 (3.27)	0	0	0	23 (18.85)	2 (1.64)	0	0	0
Very much worse	3 (2.46)	0	0	0	0	6 (4.91)	0	0	0	0
F	1095.798					1811.258
P	<0.001**					<0.001**

^*Both “*” and “**” indicate P < 0.05, signifying that the results are statistically significant.

Cheek Bone Augmentation

Cheek bone augmentation was assessed at baseline; immediately at postoperative day 0; and at 3 months, 6 months, and 1 year after the procedure. At the 1-year follow-up, no wrinkles were found in 55.74% of the patients on the left side and 72.13% of the patients on the right side. At the 6-month follow-up, no wrinkles were observed in 58.20% of the patients, indicating the best response at 6 months duration after the procedure (P < 0.05) (Table 5).

Table 5.

Cheek Bone Augmentation

	Left, n (%)					Right, n (%)
	Baseline	F1	F2	F3	F4	Baseline	F1	F2	F3	F4
No wrinkles	0	24 (19.68)	58 (47.54)	71 (58.20)	68 (55.74)	8 (6.56)	35 (28.69)	49 (40.16)	87 (71.31)	88 (72.13)
Just perceptible wrinkle	6 (4.92)	31 (25.41)	40 (32.79)	48 (39.34)	51 (41.80)	13 (10.65)	25 (20.49)	51 (41.80)	28 (22.95)	34 (27.87)
Shallow wrinkle	21 (17.21)	47 (38.53)	23 (18.85)	3 (2.46)	2 (1.64)	16 (13.11)	43 (35.24)	15 (12.29)	13 (10.65)	0
Moderately deep wrinkle	66 (54.10)	9 (7.38)	1 (0.82)	0	1 (0.82)	66 (54.10)	12 (9.84)	7 (5.74)	0	0
Deep wrinkle, well-defined edges	28 (22.95)	11 (9.02)	0	0	0	19 (15.58)	8 (6.56)	0	0	0
Very deep wrinkle, redundant fold	1 (0.82)	0	0	0	0	0	0	0	0	0
F	1505.059					5030.104
P	<0.001*					0.044**

Both “*” and “**” indicate P < 0.05, signifying that the results are statistically significant.

Cheek Bone Augmentation (No Wrinkles)

At baseline, 7.6% of patients had no wrinkles, and at 1 year (left side), 55.74% of patients had no wrinkles.

NLF Severity

In the assessment of severity of NLF, just perceptible wrinkles were found in 43.44% of the patients at day 0, 53.27% of the patients at 3 months, 59.83% of the patients at 6 months, and 55.73% of the patients at 1 year after the procedure (Fig. 2). This indicates that the severity of NLFs is most reduced between 6 months and 1 year after the procedure (P < 0.05) (Table 6). OR at 6 months/odds at baseline=1.490.768 ≈ 1.94.

Fig. 2.

Preprocedural and postprocedural changes following nasal, NLF, and chin augmentation.

Table 6.

NLF Severity

	Left, n (%)					Right, n (%)
	Baseline	F1	F2	F3	F4	Baseline	F1	F2	F3	F4
Just perceptible wrinkle	2 (1.64)	53 (43.44)	65 (53.27)	73 (59.83)	68 (55.73)	10 (8.20)	60 (49.18)	72 (59.01)	73 (59.83)	72 (59.01)
Shallow wrinkle	27 (22.13)	6 (4.92)	16 (13.11)	9 (7.37)	3 (2.46)	34 (27.86)	6 (4.92)	1 (0.82)	0	2 (1.64)
Moderately deep wrinkle	62 (50.81)	14 (11.47)	4 (3.28)	0	0	62 (50.82)	17 (13.93)	0	0	0
Deep wrinkle, well-defined edges	22 (18.03)	8 (6.55)	0	0	0	16 (13.11)	3 (2.46)	0	0	0
Very deep wrinkle, redundant fold	5 (4.10)	1 (0.82)	0	0	0	0	0	0	0	0
F	496.798					923.072
P	<0.001*					0.001**

Interpretation

An OR of 1.94 suggests a moderate improvement in NLF severity from baseline to 6 months.

Lip Enhancement

Lip enhancement was evaluated using 2 parameters: volume assessment and vermilion border definition. Volume assessment measured lip atrophy, with low atrophic lips observed in 16.39% of patients at baseline, increasing to 54.10% at day 0, 68.03% at 3 months, 88.52% at 6 months, and 90.16% at 1 year on the left side (Fig. 3).

Fig. 3.

Preprocedural and postprocedural changes following lip augmentation.

Vermilion border assessment showed a clearly defined border in 59.84% of patients on the left side (P = 0.038) and 55.74% of patients on the right side (P = 0.021) at 1 year, indicating statistically significant improvements. Results are detailed in Table 7 and illustrated in Figures 2 and 3. At baseline, 13.8% of patients had a clearly defined vermilion border. At 1 year (left side), 59.84% of patients had a clearly defined vermilion border. OR at 1 year/odds at baseline = 1.490.16 ≈ 9.31.

Table 7.

Lip Enhancement

	Left, n (%)					Right, n (%)
	Baseline	F1	F2	F3	F4	Baseline	F1	F2	F3	F4
Volume assessment
Very atrophic lips	38 (31.15)	12 (9.84)	3 (2.46)	0	0	42 (32.43)	18 (14.75)	2 (1.64)	0	1 (0.82)
Less atrophic lips	64 (52.46)	44 (36.06)	36 (29.51)	14 (11.47)	12 (9.84)	64 (52.46)	57 (46.72)	26 (21.31)	29 (23.77)	7 (5.74)
Low atrophic lips	20 (16.39)	66 (54.10)	83 (68.03)	108 (88.52)	110 (90.16)	16 (13.11)	47 (38.52)	94 (77.05)	93 (76.23)	114 (93.44)
F	2501.934					2610.142
P	0.038*					0.021*
Vermilion border assessment
Clearly defined	17 (13.93)	50 (40.98)	56 (45.90)	78 (63.93)	73 (59.84)	8 (6.56)	36 (29.51)	66 (54.10)	64 (52.46)	68 (55.74)
Medium defined	79 (64.75)	59 (48.36)	65 (53.28)	44 (36.06)	49 (40.16)	76 (62.29)	70 (57.38)	50 (40.98)	58 (47.54)	54 (44.26)
Not defined	26 (21.31)	13 (10.65)	1 (0.82)	0	0	38 (31.15)	19 (15.57)	6 (4.92)	0	0
F	1170.467					1613.030
P	<0.001**					<0.001**

Interpretation

An OR of 9.31 indicates a strong improvement in the definition of the vermilion border after 1 year. The procedure seems to have a significant positive effect on lip appearance.

Key Observations

The Spearman correlation analysis highlights the influence of demographic factors on aesthetic outcomes. Age demonstrated a significant correlation with several parameters, including a positive correlation with WSRS (wrinkles ranging from absent to extreme, Spearman correlation = 0.257–0.479, P < 0.001) and a negative correlation with cheekbone augmentation (ranging from no wrinkles to very deep wrinkle redundant fold, Spearman correlation = −0.028 to 0.142, P < 0.001) and lip volume assessment (ranging from very atrophic lips to low atrophic lips, Spearman correlation = −0.039 to 0.116, P < 0.001), reflecting well-established aging-related changes such as wrinkle severity and volume loss in the midface and lips.

Safety

The study found no adverse events related to the device, with only mild, temporary side effects commonly associated with dermal fillers, such as bruising, swelling, redness, tenderness, or mild discomfort at injection sites. These resolved spontaneously within a few days without medical intervention. The findings confirm the device’s safety for use.

DISCUSSION

This study evaluated the clinical performance, effectiveness, and safety of a 30-L HA facial filler for NLFs, cheekbone augmentation, and lip enhancement. Key findings included a significant reduction in NLF depth in 95% of patients, cheekbone volume enhancement in 90%, and improved lip volume and contouring in 85%, with no cases of overfilling or asymmetry. Cross-linking refers to the chemical bonds between HA molecules; VYC-20L is highly cross-linked, offering better stability and longer effects compared with less cross-linked fillers. The 30-L HA facial filler may have a unique cross-linking profile influencing its handling, longevity, and aesthetic outcomes, warranting direct comparison with other fillers.

The 30-L filler demonstrated effectiveness in achieving targeted aesthetic results without observed side effects, indicating a favorable safety profile. The outcomes align with existing data supporting the use of HA fillers for facial enhancement. Li et al¹⁵ reported significant volume increases and aesthetic improvements using VYC-20L in nasal corrections. Similarly, Jones et al¹⁶ confirmed the safety and effectiveness of VYC-20L for cheek augmentation in patients with moderate to severe midface volume deficit.

High-viscosity fillers like 24-L Jeunesse are often preferred for deep tissue augmentation, whereas lower viscosity fillers suit fine lines and superficial corrections. Compared with 24-L Jeunesse, the current 30-L formulation showed greater improvements in wrinkle severity and marionette line correction.¹⁷

Cohesivity refers to the ability of the filler particles to bind together, which can impact the filler’s ability to maintain shape and avoid migration after injection. High cohesivity ensures that the filler stays in place and maintains the desired volume over time, as seen with VYC-20L in studies of cheek augmentation. The 30-L HA facial filler could potentially exhibit a high level of cohesivity, contributing to the long-lasting results observed in cheekbone augmentation and wrinkle reduction.

Improvements in GAIS and WSRS scores reflect both quantitative and qualitative patient outcomes. WSRS captured objective reductions in wrinkle severity, confirmed through standardized before and after photography. GAIS, assessed by both investigators and patients, demonstrated noticeable and satisfactory aesthetic improvements, highlighting real-world relevance. Spearman correlation analysis showed that age was positively associated with increased wrinkle severity and negatively correlated with cheekbone augmentation and lip volume (P < 0.001), consistent with known aging patterns involving volume loss and skin laxity.

Additionally, dermal fillers like the 30-L formulation could extend their use to nonsurgical rhinoplasty, offering a minimally invasive correction for nasal deformities.¹⁸ Although fillers address volume loss and collagen stimulation, other modalities like micro-focused ultrasound also promote collagen production and skin tightening by targeting the deep dermis and superficial musculoaponeurotic system layers.

The 30-L HA facial filler showed safety and effectiveness for NLFs, cheekbone augmentation, and lip enhancement. Although not evaluated in this study, its use may extend to nonsurgical rhinoplasty based on established applications of HA fillers.

Facial sagging improvements have also been reported with this technology,¹⁹ although fillers offer more immediate, customizable results. No adverse reactions were observed, suggesting broad suitability; however, delayed hypersensitivity reactions after viral infections remain a consideration.^20,21

This study faced limitations in patient selection, retention, and compliance. As a single-arm design without a control group, it was difficult to conclusively attribute improvements in facial aesthetics solely to the 30-L HA facial filler. The absence of a placebo or alternative intervention further limits the strength of causal conclusions. Additionally, the population was predominantly Fitzpatrick skin types 3 and 4, restricting generalizability to lighter or thinner skin types (1 and 2), where differences in skin thickness and elasticity could affect outcomes.

Variations in posttreatment compliance and site environments may also have influenced results. Moreover, strict exclusion criteria, such as removing individuals with fillers before or certain medical conditions, limit applicability to real-world populations and may introduce bias. Future studies should include broader skin types, a control group, and more diverse patient profiles to better validate the safety and efficacy of the 30-L filler.

However, the positive outcomes of this investigation indicate a promising future for the 30-L HA facial filler. Further studies may focus on assessing long-term effectiveness and exploring potential applications in broader patient populations.

CONCLUSIONS

This study demonstrates the clinical effectiveness and safety of the 30-L HA facial filler for NLFs, cheekbone enhancement, and lip augmentation. Significant aesthetic improvements were observed, including reduced wrinkle depth, increased cheek volume, and improved lip contour, without adverse effects. The 30-L filler offers a safe, minimally invasive alternative to surgical procedures for facial rejuvenation. To strengthen these findings, future studies should include a control group and a more ethnically diverse population to enhance generalizability. Additionally, the filler’s use could extend to nonsurgical rhinoplasty and other facial contouring applications.

DISCLOSURES

This is an investigator-initiated trial, and the article processing charges were sponsored by Biotech Vision Care Pvt. Ltd., Ahmedabad, India.

PATIENT CONSENT

Patients provided written consent for the use of their images.