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Clinical efficacy and patient satisfaction of poly-L-lactic acid and ε-caprolactone-hyaluronic acid threads for graded facial laxity treatment: A prospective interventional clinical study
*Corresponding author: Saif Amthal Al-Anssari Saif Amthal Clinic, Baghdad, Iraq. saifamthal@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Al-Anssari SA. Clinical efficacy and patient satisfaction of poly-L-lactic acid and ε-caprolactone-hyaluronic acid threads for graded facial laxity treatment: A prospective interventional clinical study. CosmoDerma. 2025;5:131. doi: 10.25259/CSDM_103_2025
Abstract
Objectives:
The objective of the study is to evaluate the clinical effectiveness and patient satisfaction associated with Aptos poly-L-lactic acid and ε-caprolactone (P[LA/CL]) hyaluronic acid (HA)-enriched lifting threads (Visage Excellence Method HA), used alone or in combination with additional thread methods, across varying degrees of facial laxity as classified by the facial laxity rating scale (FLRS).
Materials and Methods:
A prospective interventional study was conducted involving 60 patients stratified by FLRS into three treatment groups: Group 1 (FLRS 2–4) received Visage Excellence Method HA in the midface; Group 2 (FLRS 5–6) received additional jawline lifting using light lift thread method; and Group 3 (FLRS 7–9) received midface, jawline, and neck lifting using both light lift thread and light lift needle methods. Assessments were conducted at baseline and at 1, 3, and 6 months post-implantation using the FLRS (clinician-assessed), FACE-Q (satisfaction with skin and outcome modules), and the Global Aesthetic Improvement Scale (GAIS). Non-parametric statistical analyses were applied.
Results:
All groups demonstrated statistically significant reductions in FLRS scores at all follow-up points (P < 0.001). A consistent 0.7–1.0 point mean decrease from baseline was sustained over 6 months, with the greatest changes observed within the first 3 months. FACE-Q satisfaction with outcome and satisfaction with skin scores increased significantly (P < 0.001), with Group 2 reporting the highest levels of satisfaction at 6 months. GAIS scores indicated “very improved” results in 97% of patients at 1 month, slightly declining by 6 months, but still reflecting positive esthetic outcomes. No serious adverse events occurred. Minor side effects, such as swelling, tightness, and bruising, were transient and resolved spontaneously within one week.
Conclusion:
P(LA/CL) HA threads, either alone or in combination with additional thread techniques, demonstrated statistically significant clinical improvements in facial laxity and high levels of patient-reported satisfaction across all severity grades. Tailoring thread-lifting strategies based on FLRS grading yields effective and safe outcomes, with the most favorable balance of clinical and subjective results observed in moderate laxity cases. These findings support the use of P(LA/CL)-HA threads as a minimally invasive, patient-centered approach to facial rejuvenation.
Keywords
Aptos threads
Facial laxity
Hyaluronic acid
Poly-L-lactic acid and ε-caprolactone threads
Thread lifting
INTRODUCTION
Facial laxity refers to the loosening or sagging of the skin and underlying structures of the face, which is commonly associated with the aging process. This condition is characterized by loss of skin elasticity and firmness, leading to the appearance of wrinkles, folds, and sagging, particularly in areas such as the eyelids, nasojugal folds, midface, jowls, and neck.[1]
The underlying causes of facial laxity include changes in the skin’s structural components, such as collagen and elastin, as well as alterations in the superficial musculoaponeurotic system, which plays a significant role in facial aging.[1] In addition, factors such as skeletal changes, loss of volume in facial fat compartments, and changes in dermal structure, including collagen and elastin, contribute to the overall appearance of facial laxity.[1]
Graded facial laxity refers to the categorization of facial skin sagging into distinct levels – mild, moderate, and severe – using validated clinical scales such as the facial laxity rating scale (FLRS).[2] This stratification allows clinicians to tailor esthetic interventions to the degree of laxity present.
Various treatment modalities have been explored to address facial laxity, starting from traditional surgical facelift to dermal fillers such as hyaluronic acid (HA) and calcium hydroxylapatite, which aim to restore volume and contribute to dermal biostimulation.[3,4]
Among emerging minimally invasive approaches, absorbable thread lifting has gained prominence for its ability to provide both immediate and gradual improvement in skin firmness and contour.[5]
Poly-L-lactic acid and ε-caprolactone (P[LA/CL]) HA-enriched threads have demonstrated promising outcomes in restoring facial contour and esthetic improvement. The Visage Excellence Method HA, a novel thread-lifting technique utilizing P(LA/CL)-based threads with HA, these threads offers structural support through mechanical lifting, stimulate neocollagenesis through the biodegradation of the copolymer, and improve tissue hydration and integration, additionally reducing inflammation due to the HA.[5-7]
Despite these advancements, optimal treatment strategies tailored to different levels of facial laxity remain underexplored.
This study aims to evaluate the effectiveness of Aptos P(LA/CL) HA-enriched lifting threads (Visage Excellence Method HA), as well as subjects’ satisfaction, implanted alone in the midface, or in combination with additional P(LA/CL) threads implanted in jowls and neck, in patients with mild to severe facial laxity, stratified according to the FLRS. This study addresses a critical gap in the literature regarding the efficacy of individualized thread-lifting strategies based on the severity of laxity. This approach allows for a more nuanced understanding of the potential benefits of combination treatments in patients with moderate-to-severe laxity, where monotherapy may be insufficient for optimal results. Validated clinical and patient-reported tools are employed to comprehensively measure lifting effect, skin quality improvement, satisfaction, and overall aesthetic outcome. We seek to determine the lifting effect, skin quality improvement, patient satisfaction, and overall esthetic improvements achieved with this approach.
MATERIALS AND METHODS
The study was conducted at Saif Amthal Clinic, Baghdad, Iraq, from December 2023 to December 2024. All procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964) and its later amendments. All participants provided written informed consent before participation, including consent for the use of clinical data and photographic documentation for scientific and publication purposes.
Patient selection
Subjects were selected based on the FLRS grading, a validated tool for assessing degrees of skin laxity in the face and neck, which includes 10 classes ranging from 0 (no laxity) to 9 (severe laxity). Patients were eligible for inclusion if they had an FLRS score ranging from class 2 to class 9.[2]
Patients who had recent facial esthetic, facial rejuvenation, cosmetic procedures, a history of any facial esthetic surgery, or facial thread lifting within the past 2 years were not included. Furthermore, recent anticoagulant or blood-thinning medication, pregnancy or breastfeeding, history of autoimmune-related skin inflammation conditions (such as lupus, scleroderma, or inflammatory dermatoses), other underlying medical conditions affecting healing, or contraindications to the treatment were the exclusion criteria.
Threads and procedure
Based on FLRS classifications, patients were divided into three groups, each group receiving a treatment protocol tailored to their degree of facial laxity:
Group 1 (mild-to-moderate laxity): 32 patients with FLRS scores of 2–4, treated with the Visage Excellence Method HA in the midface.
Group 2 (moderate laxity): 18 patients with FLRS scores of 5–6, implanted with the Visage Excellence Method HA for midface combined with the light lift thread method, placed at different angles to enhance jawline area lifting.
Group 3 (severe laxity): 12 patients with FLRS scores of 7–9, who received a combination treatment consisting of the Visage Excellence Method HA for midface, light lift thread method for jawline, and light lift needle method for the neck [Table 1 and Figure 1]. Double-ended needles were used for deeper engagement and stronger lifting, particularly in the lower face (submental area) and jawline. All threads and methods used in this study were manufactured by Aptos LLC, Georgia.
| Group | FLRS score | Treatment approach | Threads package |
|---|---|---|---|
| Group 1 (mild-to-moderate laxity) | 2–4 | Visage Excellence Method HA [Figure 1a] | P (LA/CL)+HA monofilament thread with barbs USP 2/0, EP 3, 190 mm – 10 pcs. Round-tip hollow needle, 20G×150 mm, straight – 10 pcs. Round-tip hollow needle, 23G×80 mm, straight – 1 pcs. Lancet point needle, 18×40 mm, straight – 1 pcs. Removable needle attachment. |
| Group 2 (moderate laxity) |
5–6 | Visage Excellence Method HA+Light lift thread method blunt [Figure 1b] | P (LA/CL)+HA monofilament thread with barbs USP 2/0, EP 3, 190 mm – 10 pcs. Round-tip hollow needle, 20G×150 mm, straight – 10 pcs. Round-tip hollow needle, 23G×80 mm, straight – 1 pcs. Lancet point needle, 18×40 mm, straight – 1 pcs. Removable needle attachment. + P (LA/CL) monofilament thread with barbs USP 2/0, EP 3, 250 mm – 2 pcs. Blunt-tip hollow needle, 21G×100 mm, straight – 4 pcs. Standard needle attachment. |
| Group 3 (severe laxity) |
7–9 | Visage Excellence Method HA+Light lift thread method blunt+Light lift needle method, blunt [Figure 1c] | P (LA/CL)+HA monofilament thread with barbs USP 2/0, EP 3, 190 mm – 10 pcs. Round-tip hollow needle, 20G×150 mm, straight – 10 pcs. Round tip hollow needle 23G×80 mm, straight – 1 pcs. Lancet point needle 18×40 mm, straight – 1 pcs. Removable needle attachment. + P (LA/CL) monofilament thread with barbs USP 2/0, EP 3, 250 mm – 2 pcs. Blunt-tip hollow needle, 21G×100 mm, straight – 4 pcs. Standard needle attachment. + P (LA/CL) monofilament threads with bidirectional barbs USP 2/0, EP 3, 500 mm – 2pcs. Blunt-tip hollow needle, 21G×110 mm, straight – 4 pcs. Standard needle attachment. |
EVHA: Visage Excellence Method, HA: Hyaluronic acid, LLTMB: Light lift thread method blunt, LLNMB: Light lift needle method blunt,P (LA/CL): Poly-L-lactic acid and ε-caprolactone, FLRS: Facial laxity rating scale, USP: United States Pharmacopoeia, EP: European pharmacopoeia.
- (a) Visage Excellence Method hyaluronic acid (HA), (b) Visage Excellence Method HA+thread method, (c) Visage Excellence Method HA+thread method+needle method.
The procedures were performed under local anesthesia with lidocaine and epinephrine, following standard implantation techniques. Threads were carefully positioned along pre-marked vectors, and tissues were lifted and secured by engaging the barbs. Post-procedure care included cold compress application, avoidance of excessive facial movement, and activity restrictions to ensure optimal healing. Follow-up assessments were conducted to monitor outcomes and patient satisfaction [Figure 1].
Assessment tools
Assessments were conducted at 1, 3, and 6-month follow-up visits to the clinic.
FLRS is a clinician-graded tool used to assess facial and neck laxity across the upper face, middle face, lower face, and neck. FLRS is a 10-class photo numeric scale, where class 0 represents no laxity, and classes 1–9 indicate increasing degrees of laxity. Mild laxity is classified as 1–3, moderate laxity as 4–6, and severe laxity as 7–9.[2]
FACE-Q questionnaires (FACE-Q© 2013 Memorial Sloan-Kettering Cancer Center)[8] are validated and widely used patient-reported outcome instruments. The following modules were used:
Satisfaction with the skin module includes 12 questions regarding the subjects’ impressions of their facial skin’s appearance, attractiveness, freshness, hydration, radiance, and smoothness. It was filled with subjects before thread implantation and 1, 3, and 6 months after implantation.
The satisfaction with outcome module includes 6 questions on patients’ overall satisfaction with the results of their facial aesthetic procedures. It was filled with subjects on each visit after the thread implantation.
The Global Aesthetic Improvement Scale (GAIS) is a clinician-reported tool used to assess overall esthetic improvement following cosmetic procedures. The score of 1 refers to “exceptional improvement,” 2 refers to “very improved,” 3 refers to “improved,” 4 refers to “unaltered,” and 5 refers to “worsened.” In this study, physicians completed the GAIS assessments at 1-month, 3-month, and 6-month intervals.[9]
Data collection and analysis
The main objective of this study was to evaluate the effectiveness of the intervention in reducing facial laxity, measured by a decrease in the FLRS score at follow-ups.
All statistical analyses were performed using the R statistical language (version 4.4.3) (R Core Team, 2025).[10] Descriptive statistics were calculated for all variables and presented as means and standard deviations (SD), and as medians, interquartile ranges, and ranges. FACE-Q domain scores were computed in accordance with the instrument’s scoring guidelines, including Rasch transformation of raw responses as recommended by the FACE-Q manual. Assessing changes in FLRS scores, the assumption of normality was not met, as determined by the Shapiro–Wilk test and visual inspection of Q–Q plots conducted in R. As a result, non-parametric alternatives were applied. For intragroup comparisons across time points, the Wilcoxon signed-rank test was employed due to the non-parametric nature of the data. Intergroup comparisons were conducted using the Kruskal–Wallis test. A P < 0.05 was considered indicative of statistical significance. Bonferroni correction was used to adjust for multiple comparisons. For the Wilcoxon signed-rank test, the effect size (r) was calculated, with r < 0.3 indicating a small effect, 0.3 ≤ r < 0.5 denoting a medium effect, and r ≥ 0.5 corresponding to a large effect.
RESULTS
Study subjects
A total of 60 patients were enrolled in the study, including 56 women (93%) and 4 men (6.7%). Participants were stratified into three groups based on the degree of facial laxity: Group 1 (G1; n = 32), Group 2 (G2; n = 16), and Group 3 (G3; n = 12).
The mean age of the study population (±SD) was 39.6 ± 10.9 years, with a range of 24 to 67 years. G1 (mild to moderate laxity) had the youngest mean age of 35.1 years, while G3 (severe laxity) had the highest mean age of 55.9 years [Table 2].
| Overall n=60 (%) | G1 (FLRS 2–4) n=32 (%) | G2 (FLRS 5–6) n=16 (%) | G3 (FLRS 7–8) n=12 (%) | |
|---|---|---|---|---|
| Gender, n(%) | ||||
| Female | 56 (93) | 30 (94) | 15 (94) | 11 (92) |
| Male | 4 (7) | 2 (6) | 1 (6) | 1 (8) |
| Age | ||||
| Mean (SD) | 39.6 (10.9) | 35.1 (6.3) | 36.3 (6.5) | 55.9 (10.3) |
| Median (IQR) | 37.0 (13.3) | 34.5 (9.5) | 36.0 (10.5) | 59.0 (13.0) |
| Min, Max | 24.0, 67.0 | 24.0, 46.0 | 27.0, 50.0 | 33.0, 67.0 |
| Skin laxity | ||||
| Mean (SD) | 4.7 (2.0) | 3.1 (0.8) | 5.3 (0.4) | 8.0 (1.0) |
| Median (IQR) | 4.0 (3.0) | 3.0 (1.0) | 5.0 (0.3) | 8.0 (2.0) |
| Min, Max | 2.0, 9.0 | 2.0, 4.0 | 5.0, 6.0 | 7.0, 9.0 |
FLRS: Facial laxity rating scale, SD: Standard deviation, IQR: Interquartile range
Baseline mean (±SD) FLRS score was 4.7 ± 2.0 across the full cohort. The mean FLRS scores were consistent with group stratification: 3.1 ± 0.8 in G1, 5.3 ± 0.4 in G2, and 8.0 ± 1.0 in G3 [Table 2].
Results of FLRS assessment
One month post-treatment, the behavior of FLRS scores was similar in all groups: A decrease from baseline by 0.8–1 point was observed for mean values [Table 3]. The overall FLRS mean statistically significantly dropped to 3.8 ± 2.0 (P = 0.000, r = 0.922, Wilcoxon signed-rank test with Bonferroni correction). Similarly, FLRS scores decreased to 2.3 ± 0.7 in G1, to 4.3 ± 0.5 in G2, and to 7.1 ± 0.9 in G3. These results were maintained at the 3-month follow-up, with the overall mean score remaining statistically significantly below baseline at the level of 3.8 ± 2.0 (P = 0.000, r = 0.922, Wilcoxon signed-rank test with Bonferroni correction).
| FLRS score | Overall (n=60) | G1 (n=32) | G2 (n=16) | G3 (n=12) |
|---|---|---|---|---|
| Baseline | ||||
| Mean (SD) | 4.7 (2.0) | 3.1 (0.8) | 5.3 (0.4) | 8.0 (1.0) |
| Median (IQR) | 4.0 (3.0) | 3.0 (1.0) | 5.0 (0.3) | 8.0 (2.0) |
| Min, Max | 2.0, 9.0 | 2.0, 4.0 | 5.0, 6.0 | 7.0, 9.0 |
| Month 1 | ||||
| Mean (SD) | 3.8 (2.0)* | 2.3 (0.7)* | 4.3 (0.5)* | 7.1 (0.9)* |
| Median (IQR) | 3.0 (3.0) | 2.0 (1.0) | 4.0 (1.0) | 7.0 (2.0) |
| Min, Max | 1.0, 8.0 | 1.0, 4.0 | 4.0, 5.0 | 6.0, 8.0 |
| Month 3 | ||||
| Mean (SD) | 3.8 (2.0)* | 2.3 (0.6)* | 4.3 (0.5)* | 7.2 (0.8)* |
| Median (IQR) | 3.0 (3.0) | 2.0 (1.0) | 4.0 (1.0) | 7.0 (1.3) |
| Min, Max | 1.0, 8.0 | 1.0, 3.0 | 4.0, 5.0 | 6.0, 8.0 |
| Month 6 | ||||
| Mean (SD) | 4.0 (2.1)*,**,# | 2.4 (0.8)* | 4.6 (0.6)* | 7.3 (1.0)* |
| Median (IQR) | 3.5 (3.0) | 2.0 (1.0) | 4.5 (1.0) | 7.5 (1.3) |
| Min, Max | 1.0, 9.0 | 1.0, 4.0 | 4.0, 6.0 | 6.0, 9.0 |
FLRS: Facial laxity rating scale, SD: Standard deviation, IQR: Interquartile range. *FLRS scores statistically significantly different from the corresponding value in the same group at baseline (Wilcoxon signed-rank test with Bonferroni correction, P<0.05). **Statistically significantly different from the corresponding value in the same group 1 month after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05). #Statistically significantly different from the corresponding value in the same group 3 months after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05)
By month 6, the FLRS score reduction became less pronounced, although still statistically significantly lower than at baseline (P = 0.000 for total FLRS value, r = 0.837, Wilcoxon signed-rank test with Bonferroni correction). Although different in absolute FLRS values, all three groups and the total population retained a similar reduction by 0.7 points from baseline by the 6-month follow-up. The range of scores also widened at this point in all groups, reflecting higher variability in long-term treatment response. Figure 2 illustrates the distribution of FLRS scores throughout the population at all timepoints.
- Violin plots for facial laxity rating scale scores observed after thread implantation in the total population. Horizontal line represents the median value, the box indicates the 25% and 75% quartiles, and the maximum and minimum are shown as the upper and lower points.
FACE-Q satisfaction with outcome
Overall, mean values (±SD) for the Rasch-transformed FACE-Q satisfaction with outcome scores were 79.3 ± 16.3, 89.1 ± 10.6, and 88.4 ± 10.8 at 1, 3, and 6-month post-treatment, respectively [Table 4].
| Overall (n=60) | G1 (n=32) | G2 (n=16) | G3 (n=12) | |
|---|---|---|---|---|
| 1-month post-treatment | ||||
| Mean (SD) | 79.3 (16.3) | 75.6 (18.5) | 84.1 (13.5) | 83.0 (11.2) |
| Median (IQR) | 79.0 (32.0) | 76.0 (31.3) | 83.0 (22.5) | 79.0 (12.8) |
| Min, Max | 41.0, 100.0 | 41.0, 100.0 | 59.0, 100.0 | 68.0, 100.0 |
| 3-month post-treatment | ||||
| Mean (SD) | 89.1 (10.6)* | 87.8 (10.8)* | 93.0 (7.5) | 87.3 (12.8) |
| Median (IQR) | 87.0 (21.0) | 87.0 (21.0) | 93.5 (13.0) | 87.0 (27.0) |
| Min, Max | 63.0, 100.0 | 63.0, 100.0 | 79.0, 100.0 | 68.0, 100.0 |
| 6-month post-treatment | ||||
| Mean (SD) | 88.4 (10.8)* | 88.0 (10.6)* | 93.8 (7.5)*,# | 82.2 (12.4) # |
| Median (IQR) | 87.0 (21.0) | 87.0 (21.0) | 100.0 (13.0) | 79.0 (12.8) |
| Min, Max | 63.0, 100.0 | 63.0, 100.0 | 79.0, 100.0 | 63.0, 100.0 |
FLRS: Facial laxity rating scale, SD: Standard deviation, IQR: Interquartile range. *Rasch-transformed FACE-Q scores were statistically significantly different from the corresponding value in the same group 1 month after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05). #Statistically significant difference between G2 and G3 6 months after implantation (pairwise comparison, Wilcoxon signed-rank test with Bonferroni correction, P<0.05).
At 1-month follow-up, FACE-Q scores were generally high across all groups, with Group 2 reporting the highest mean satisfaction (84.1 ± 13.5); no statistical difference was observed between groups.
By 3 months, satisfaction scores increased across all groups, reaching statistical significance compared to 1 month in G1 (Wilcoxon signed-rank test with Bonferroni correction, P = 0.005) and in the total population (P = 0.000, r = 0.520, Wilcoxon signed-rank test with Bonferroni correction). These high levels were maintained at 6 months: statistically significant improvements compared to 1-month follow-up were observed in G1 (P = 0.003) and G2 (P = 0.042) as well as in the total population (P = 0.001, r = 0.487; [Table 3]). Overall comparison showed statistically significant differences between minimum two of the three groups at 6 months (Kruskal–Wallis test with Bonferroni correction; χ2 = 8.092, P = 0.018). Subsequent pairwise intergroup comparison at 6 months showed statistically significantly higher FACE-Q score in the G2 group compared to G3 at 6 months (Wilcoxon signed-rank test with Bonferroni correction, P = 0.023).
Figure 3 illustrates the distribution of FACE-Q scores after thread implantation. Following the procedure, the scores are predominantly concentrated in the upper part of the plot. The box-and-whisker plot within the violin is also shifted toward higher values and skewed upward, indicating a distributional shift toward higher – and often maximal – scores.
- Percentages of responses to individual questions of the face-Q satisfaction with Outcome at follow-ups 1, 3, and 6 months after thread implantation.
FACE-Q satisfaction with the skin
Overall, FACE-Q satisfaction with skin score statistically significantly increased from 72.2 ± 13.3 at 1-month post-treatment to 88.9 ± 7.8 at 3 months (P = 0.000, r = 0.851, Wilcoxon signed-rank test with Bonferroni correction) and 86.3 ± 7.1 at 6 months (P = 0.000, r = 0.772). By 6 months after implantation, a minor decrease was observed.
G2 (moderate laxity) had the highest mean scores across all time points: 76.1 ± 13.5 (1 month), 91.8 ± 7.4 (3 months), and 89.7 ± 6.8 (6 months); however, there were no statistically significant differences between groups at any time point. G3 (severe laxity) initially had the lowest score at 1 month (67.2 ± 13.5) but further reached values similar to those observed in the two other groups: 88.1 ± 9.9 and 82.9 ± 7.5, respectively, for 3- and 6-month follow-ups [Table 5].
| Total (n=60) | G1 (n=32) | G2 (n=16) | G3 (n=12) | |
|---|---|---|---|---|
| 1-month post-treatment | ||||
| Mean (SD) | 72.2 (13.3) | 72.2 (12.9) | 76.1 (13.5) | 67.2 (13.5) |
| Median (IQR) | 69.0 (17.3) | 70.5 (19.0) | 70.5 (23.0) | 66.0 (11.8) |
| Min, Max | 51.0, 100.0 | 51.0, 100.0 | 61.0, 100.0 | 51.0, 100.0 |
| 3-month post-treatment | ||||
| Mean (SD) | 88.9 (7.8)* | 87.8 (7.1)* | 91.8 (7.4)* | 88.1 (9.9)* |
| Median (IQR) | 88.0 (9.0) | 88.0 (9.8) | 90.5 (13.0) | 88.0 (11.5) |
| Min, Max | 67.0, 100.0 | 76.0, 100.0 | 81.0, 100.0 | 67.0, 100.0 |
| 6-month post-treatment | ||||
| Mean (SD) | 86.3 (7.1)*,** | 85.8 (6.5)* | 89.7 (6.8)* | 82.9 (7.5)*,** |
| Median (IQR) | 88.0 (7.0) | 86.0 (7.0) | 88.0 (10.8) | 84.0 (7.0) |
| Min, Max | 65.0, 100.0 | 74.0, 100.0 | 81.0, 100.0 | 65.0, 93.0 |
FLRS: Facial laxity rating scale, SD: Standard deviation, IQR: Interquartile range. *Rasch-transformed FACE-Q scores were statistically significantly different from the corresponding value in the same group 1 month after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05). **Statistically significantly different from the corresponding value in the same group 3 months after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05)
Throughout the 6-month follow-up period, response patterns to individual items on both FACE-Q questionnaires consistently shifted toward a stronger predominance of “very satisfied” ratings, with a complete or near-complete absence of non-satisfied responses by the 6-month mark [Figure 4]. Figure 4 illustrates the distribution of scores for individual questions among participants in the study population.
- Percentages of responses to individual questions of the face-Q satisfaction with skin at follow-ups 1, 3, and 6 months after thread implantation.
Results of GAIS assessment
GAIS scores demonstrated consistent esthetic improvement across all patient groups throughout the 6-month follow-up period [Table 6]. One month post-treatment, the mean GAIS scores were 2.2 ± 0.7 for G1, 1.7 ± 0.7 for G2, and 2.1 ± 0.9 for G3, indicating positive clinical outcomes corresponding to a score around GAIS = 2 (“very improved”) as early as 1 month after thread implantation. These values remained stable through the 3-month follow-up and showed a slight increase by month 6, with G1 reaching a mean of 2.5 ± 0.7, G2 at 2.2 ± 0.7, and G3 at 2.3 ± 0.9. No statistically significant differences were observed between the groups at any time point.
| Timepoint | Parameter | G1 (n=32) (%) | G2 (n=16) (%) | G3 (n=12) (%) | Total (%) |
|---|---|---|---|---|---|
| GAIS score | |||||
| 1 month | Mean (SD) | 2.2 (0.7) | 1.7 (0.7) | 2.1 (0.9) | 2.0 (0.77) |
| Median (IQR) | 2.0 (1.0) | 2.0 (1.0) | 2.0 (2.0) | 2.0 (2.00) | |
| Min, Max | 1.0, 4.0 | 1.0, 3.0 | 1.0, 3.0 | 1.0, 4.0 | |
| 3 months | Mean (SD) | 2.2 (0.7) | 1.7 (0.7) | 2.1 (0.9) | 2.1 (0.8) |
| Median (IQR) | 2.0 (1.0) | 2.0 (1.0) | 2.0 (2.0) | 2.0 (1.3) | |
| Min, Max | 1.0, 4.0 | 1.0, 3.0 | 1.0, 3.0 | 1.0, 4.0 | |
| 6 months | Mean (SD) | 2.5 (0.7)*,** | 2.2 (0.7) *,** | 2.3 (0.9) *,** | 2.4 (0.7)*,** |
| Median (IQR) | 3.0 (1.0) | 2.0 (1.0) | 2.5 (1.3) | 2.00 (1.00) | |
| Min, Max | 1.0, 4.0 | 1.0, 3.0 | 1.0, 3.0 | 1.00, 4.00 | |
| Subjects per GAIS grade, n(%) | |||||
| 1 month | Exceptional improvement | 5 (16) | 7 (44) | 4 (33) | 16 (27) |
| Very improved | 18 (56) | 7 (44) | 3 (25) | 28 (47) | |
| Improved | 8 (25) | 2 (13) | 5 (42) | 15 (25) | |
| Unaltered | 1 (3) | 0 (0) | 0 (0) | 1 (1.7) | |
| 3 months | Exceptional improvement | 4 (13) | 7 (44) | 4 (33) | 15 (25) |
| Very improved | 18 (56) | 7 (44) | 3 (25) | 28 (47) | |
| Improved | 9 (28) | 2 (13) | 5 (42) | 16 (27) | |
| Unaltered | 1 (3) | 0 (0) | 0 (0) | 1 (1.7) | |
| 6 months | Exceptional improvement | 3 (9.4) | 2 (13) | 3 (25) | 8 (13) |
| Very improved | 11 (34) | 9 (56) | 3 (25) | 23 (38) | |
| Improved | 17 (53) | 5 (31) | 6 (50) | 28 (47) | |
| Unaltered | 1 (3) | 0 (0) | 0 (0) | 1 (1.7) | |
FLRS: Facial laxity rating scale, SD: Standard deviation, IQR: Interquartile range, GAIS: Global Aesthetic Improvement Scale. *GAIS score statistically significantly different from the corresponding value in the same group 1 month after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05). **Statistically significantly different from the corresponding value in the same group 3 months after implantation (Wilcoxon signed-rank test with Bonferroni correction, P<0.05)
However, by month 6, GAIS scores in G1, G2, and the overall population were statistically significantly higher – indicating slightly less pronounced improvement – compared to those at month 1 (P = 0.003, P = 0.012 for G1 and G2, respectively; P = 0.000, r = 0.350 for the total population) and month 3 (P = 0.010, P = 0.012 for G1 and G2, respectively; P = 0.000, r = 0.387 for the total population), based on the Wilcoxon signed-rank test with Bonferroni correction. Despite this modest decline, scores remained within the range of GAIS = 2 (“very improved”) to GAIS = 3 (“improved”).
Median GAIS scores were consistently at GAIS = 2 through month 3 and increased slightly by month 6, reaching GAIS = 3 in G1 and 2.5 in G3. Score ranges across all groups remained stable, spanning from 1 (“unaltered”) to 4 (“exceptional improvement”), reflecting consistent grading standards over time. Notably, the score of 1 was consistently reported by a single subject (3%) in G1 throughout the study, while all other participants in all groups showed at least some degree of improvement [Figure 5 and Table 6].
- Percentages of subjects per Global Aesthetic Improvement Scale grade at follow-ups 1, 3, and 6 months after thread implantation. 1 – exceptional improvement, 2 – very improved, 3 – improved, 4 – unaltered.
Pictures of before the procedure and after are demonstrated in Figures 6-8.
- Group 1 (a) before the treatment (b) after 6 months.
- Group 2 (a) before the treatment (b) after 6 months.
- Group 3 (a) Before the treatment (b) After 6 months.
Safety profile
No unexpected or serious adverse events occurred. Among the 60 patients treated, the observed adverse events included swelling (63.3%), feeling of tightness (46.7%), bruising (38.3%), and pain (23.3%). All these events were anticipated due to the nature of the procedure, which, although being minimally invasive, commonly leads to transient local irritation or mild foreign body reactions. All adverse events were mild in severity, related to thread implantation, and resolved spontaneously within 3–7 days without requiring additional intervention. Symptoms appeared within the 1st day following the procedure and completely subsided within the expected time frame. Consequently, the study confirms the favorable safety profile of the lifting threads utilized.
DISCUSSION
Our study demonstrates that P(LA/CL)-HA threads – specifically the Visage Excellence Method HA – either used alone or in combination with the light lift thread or needle method, offer effective facial lifting and high levels of patient satisfaction across different degrees of skin laxity.
The study revealed a statistically significant improvement in FLRS scores across the entire study population as early as 1 month post-treatment. This improvement was consistently around 0.8–1 point, irrespective of initial facial laxity. FLRS scores exhibited the most pronounced improvement within the first 3 months, particularly in patients with mild laxity (Group 1). By 6 months, although absolute FLRS values differed, all three groups and the total population maintained a similar reduction of approximately 0.7 points from baseline. These findings indicate that treatment selections were appropriately matched to different laxity levels, producing comparable improvements even in the severe laxity group.
Although the FLRS has been introduced and validated previously,[2] the minimal clinically important difference for the FLRS has not yet been clearly described in the literature. Nonetheless, the observed FLRS score changes in this study demonstrated statistically significant effect sizes, as confirmed by the Wilcoxon test. Further research to establish clinical significance thresholds would enhance the interpretability of FLRS score changes. Despite this limitation, detailed FLRS grading remains valuable as it allows rigorous statistical analysis and assessment of changes in various facial areas.
FACE-Q and GAIS assessments are more widely utilized than FLRS, with FACE-Q approved by the Food and Drug Administration for esthetic procedure evaluations. In this study, FACE-Q questionnaires revealed distinct differences between groups and assessment timepoints, indicating the highest patient satisfaction in cases of moderate laxity (Group 2). GAIS scores remained consistently positive but indicated a slight decrease at 6 months, reflecting the gradual diminishment of improvement anticipated. This suggests that in the context of subjects, satisfaction thread treatments alone or in combination are particularly suitable for mild-to-moderate laxity cases. Conversely, severe laxity cases (particularly classes 8 and 9) showed comparatively lower satisfaction levels, suggesting that optimal outcomes in advanced laxity patients may require thread treatments combined with other esthetic interventions. Tailored combination approaches thus appear essential for maximizing satisfaction and effectiveness in severe laxity.
When compared with findings from Lam et al. (2022),[11] who evaluated the effect of lifting using PLGA bidirectional cone sutures in 10 Asian patients through FLRS and FACE-Q, notable similarities and differences emerged. Lam et al.’s study had a small sample size (n = 10), limiting generalizability, statistical robustness, and applicability. In contrast, our larger study involved 60 subjects and utilized non-parametric statistics, enhancing result reliability.
Both studies observed significant midface improvement shortly after treatment. While Lam et al.[11] reported a steady improvement up to 12 months, sustained through 24 months, our results indicated similar immediate lifting effects in mild laxity cases (Group 1) and the highest patient satisfaction in moderate laxity cases (Group 2). Lam et al.[11] noted delayed lower face improvement, appearing after 3 months, which was also observed in this study. The combined thread and needle techniques utilized in this study appeared to optimize outcomes even in more advanced cases. High patient satisfaction was consistently noted in both studies, progressively increasing during the follow-up period, with the highest values at 3–6 months.
Importantly, both methods demonstrated excellent safety profiles with minimal side effects. Lam et al. [11] attributed their safety outcomes to the cone-based thread design, whereas our findings support previous reports suggesting HA-coated P(LA/CL) threads enhance tissue hydration, integration, and overall safety compared to non-HA threads.[7]
Georges Ziade et al. suggested that this safety benefit might result from the HA, reducing friction during insertion and enhancing tissue integration.[7] In addition, recent preclinical data from a porcine model further indicate potential skin-quality benefits provided by HA-enriched P(LA/CL) threads.[5]
In summary, our findings support the added advantages of personalized techniques and HA-coated threads, particularly in enhancing satisfaction and skin quality.
CONCLUSION
This study demonstrates that the Visage Excellence Method HA, alone or in combination with thread and needle techniques, provides a safe and effective minimally invasive solution for facial laxity treatment. Across all severity groups, patients experienced significant esthetic improvement, as shown by reductions in FLRS scores and high satisfaction. Improvements were visible as early as the first follow-up, 1-month post-implantation, and sustained throughout the 6-month follow-up period, aligning with known timelines for both mechanical lifting and biostimulatory collagen remodeling. These findings confirm the effectiveness of P(LA/CL)-HA threads and highlight the importance of tailored treatment strategies based on objective initial facial skin laxity assessment. The method offers a valuable alternative for patients seeking effective facial rejuvenation with minimal downtime.
Ethical approval:
The research/study was approved by the Institutional Review Board at Saif Amthal Clinic, number 2023/11-1, dated November 20, 2023.
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent.
Conflicts of interest:
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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