The third generation barbed lifting threads: Added value of hyaluronic acid

Facial thread lifting is a highly demanded procedure in esthetic clinics worldwide. The aim of this retrospective study is to evaluate the clinical effectiveness and overall patients’ satisfaction of a new generation of barbed threads, in which a hyaluronic acid (HA) coat was added to the PLLA/PCL threads and compare the results with PLLA/PCL threads without HA.

studies of biostimulating barbed threads made of polylactic acid and polycaprolactone [P(LA/CL)] have demonstrated the safety of application followed by a long term clinical satisfaction. 2,3ort recovery period with the reduced adverse effects, quicker functioning time and long lasting effects are key elements to build up the satisfaction with threadlifting.Numerous technical details play vital roles in enhancing the overall satisfaction with threadlifting among which are the type of barbs, barb angulation, distance between barbs, and the choice of administration techniques for different clinical indications. 4Nevertheless, the thread material (its composition) has a cardinal impact in delivering the skin rejuvenation effects and, therefore, the patients' satisfaction with the results.The thread-tissue interaction is becoming over the recent years based more on biostimulation rather than fibrotic reaction. 5,6e later was mainly noted by the addition of polycaprolactone to threads as a tool for a higher neocollagnesis. 7,8tely, a new generation of threads in which a hyaluronic acid (HA) coat was added to the P(LA/CL) threads (75% Polylactic acid and 25% polycaprolactone) has been introduced to the aesthetic fields.HA is a revolutionary substance as safe and biodegradable filler that does not need a prior skin test compared to collagen fillers. 9HA fillers have been proven to improve skin quality by attracting water to the extracellular matrix.Addition of HA to the latest version of threads aims a better skin reparation following face lifting.Combining HA treatment with the threadlifting technique in one procedure might significantly boost the clinical outcome and reduce the adverse side effects at the recovery time.This is the first study that looks at the short and long term benefits of adding HA to the lifting barbed threads.Two groups of patients are compared, one receiving P(LA/CL) threads with HA and another-P(LA/CL) threads without HA.The lesser skin adverse effects after procedure and a better skin quality in a long term in the first treatment group indicate the added value of HA in P(LA/CL) lifting barbed threads.

| Subjects
After getting the Lebanese University IRB approval, 20 patients were included in this retrospective study: 12 patients for whom the P(LA/CL) threads with HA was used and eight patients for whom P(LA/CL) threads without HA were applied.The selection of the procedure was based only on the clinical indication for patients presenting with facial sagging.There was not any selective choice whether to use threads with or without HA for the studied subjects and proceeding with any of the different threads was based solely on the available clinic stock.Thread lifting procedures had been carried out at the principal investigator's clinic.Informed consent and consent for publication were obtained from every study subject.Inclusion criterion was an aging facial appearance graded with 10-100 points according to the visual scales.Exclusion criteria were: any previous use of facial threads or previous facial aesthetic surgery within the last 2 years, previous skin rejuvenation therapy that includes radiofrequency or high intensity focused ultrasound therapy done within the last 12 months, and any facial cosmetic procedures including the use fillers or skin treatment except the use of facial cleansers and sunscreens within 12 months of undergoing the thread lifting.

| Technique description
After clinical examination, all patients underwent threadlifting procedure using P(LA/CL) threads or P(LA/CL) threads with HA.The used package consisted of ten 190 mm blunt cannulas in which multidirectional barbs threads were already introduced a 23G blunt cannula for local anesthesia infiltration, and an 18G needle to make the entry point.The procedure was done under local anesthesia in an outpatient setting using the sterile technique.A single entry point was created at the zygomatic arch level from which Lidocaine (1%) with 1:00000 epinephrine is infiltrated using the previously mentioned blunt cannula.Then five threads were introduced on each side of the face: The first one directed towards the midcheek, the second towards the nasolabial fold, the third towards the marionette line, the fourth towards the jowl, and the fifth vertically towards the jaw angle.
No garment was used after the procedure and patients were mainly instructed to sleep on their back during the first week, avoid excessive heat for 2 weeks, and avoid excessive facial movements during the first week.

| Data collection
Data were collected in the principle investigator's clinic.Collected demographic data included age, gender, and general medical history of the patients.All included patients were asked to fill the correspondent Face-Q-patient reported outcome questionnaire (FACE-Q© 2013 Memorial Sloan-Kettering Cancer Center, all rights reserved).The domains reported in the Face-Q are: Age visual analogue scale, psychological function, satisfaction with skin, satisfaction with facial appearance, appraisal of nasolabial folds, lower face, skin adverse effects, and early life impact of treatment.The

| Statistical analysis
Data of the Face-Q and GAIS along with the participants' age and gender was entered in the dataset.SPSS version 24 was used for data analyses.Means and standard deviations (SD) were used to describe demographic variables.The scale questions were summed based on the Face-Q recommendations.Intragroup comparison on all endpoints was performed between baseline, 4 months and at end of study (12 months, with an interval of +/− 2 months) using the paired t test.Intergroup comparison was done for different endpoints at different time points using the unpaired student t test.p Value < 0.05 was considered statistically significant.

| RE SULTS
The mean age for the group treated with P(LA/CL) threads with HA was 40.8 years and the mean age for the group treated with P(LA/ CL) threads without HA was 41.1 years.All patients in both groups were females.
The FaceQ scales: Age appraisal, Psychological function, Skin satisfaction, Satisfaction with facial appearance, Appraisal lines of nasolabial folds, and Satisfaction with lower face and jaw were similar in the groups treated with P(LA/CL) threads with HA or treated with P(LA/CL) threads without HA.Seemingly, addition of HA has not altered the Early impact on life at 1 week in the FaceQ scale (Table 1).Interestingly though, there was a significant difference between the groups, in favor of the group treated with P(LA/CL) threads with HA, at baseline in terms of adverse events regarding the skin a week after the procedure (Table 1).
Of great importance, based on the data collected about the side effects seen at 1 week after the treatment, in the group treated with P(LA/CL) threads with HA there was less skin redness, an overall reduced level of uneven skin tone and diminished parts not looking smooth.In the same line, itching and burning sensations were negligibly present in the patients receiving P(LA/CL) threads with HA (Figure 1A,B).
Intragroup comparisons of the FaceQ scales from baseline to 4 months after procedure and from baseline to 12 months after procedure performed separately for the group treated with P(LA/ CL) threads with HA (Table 2) and the group treated with P(LA/CL) threads without HA (Table 3) demonstrated the significant improvements among all the scales for both groups.Interestingly, intragroup comparison of the FaceQ scales from 4 months to 12 months after procedure there was a significant difference in the reporting of aging appearance, satisfaction with face appearance, lower jaw and face in the group treated with P(LA/CL) threads with HA (Table 2).In contrast, only the level of the satisfaction with facial appearance was significantly improved from 4 to 12 months in the group treated with P(LA/CL) threads without HA (Table 3).
Intergroup comparison of the FaceQ scales between the two studied groups at 4 months revealed a significantly higher improvement in skin satisfaction among patients treated with P(LA/CL) threads with HA (Table 4).At 12 months, the significantly improved skin satisfaction and lower jaw and face were revealed in the group treated with P(LA/CL) threads with HA compared to the group treated with P(LA/CL) threads without HA (Table 4).

GAIS scores reported by patients and by two physicians by
looking to each patient's photos taken before the procedure and four and 12 months post-treatment (Figure 2) indicated benefits of HA-containing threads in a long term shown in the intergroup comparison at the endpoint (12 months post-treatment) of the study (Table 5).

| DISCUSS ION
Thread lifting as an efficient minimally invasive anti-aging procedure has become the most demanded skin lifting and rejuvenating option in an aesthetic world. 1 Absorbable lifting threads underwent major improvement in their core products and applied techniques throughout the years.
Among various compositions of threads present on the market nowadays, polydioxanone (PDO) threads are widely used in TA B L E 1 Demographic data and the early impact on life at 1 week in the groups treated with P(LA/CL) threads with HA versus P(LA/CL) threads without HA.
esthetics.PDO threads undergo hydrolysis, which leads to their absorption over 6 months and a total loss of resistance occurs in about 63 days, which limits their clinical efficacy and longterm patient satisfaction. 10Investigations behind the mechanism of action of PDO threads have uncovered that their clinical effect is mainly achieved by the formation of fibrous connective tissue along the thread, and the contraction of myofibroblasts during the degradation process of the material.Different clinical outcomes were seen depending on the PDO brand used with high variability in the results in terms of biocompatibility and secondary metabolic activity with the same evidence of cytotoxicity in some of the products used. 10,11lylactic acid (PLLA) threads were developed later and gained a high interest among aesthetic practitioners due to their higher collagen-stimulating properties and longer effect when compared to PDO threads. 12PLLA, because of its easily regulated degradation profile, is now an FDA approved, biocompatible, and absorbable polymer with biologically appropriate mechanical properties. 13,14 the skin level, PLLA threads lead to the formation of collagen and have a volumizing effect based on its ability to trigger a lowgrade inflammatory response.This provides a better overall facial appearance along with the lifting. 13Noteworthy, injectable PLLA as a dermal filler has shown an increased radiance and skin smoothness 12 months after the injection and reduced adverse effects such as skin erythema, uneven pigmentation and pore size. 15,16ter, polycaprolactone (PCL) based dermal fillers and lifting threads had shown even stronger biostimulating outcomes than PLLA products through their enhanced property of neocollagenesis resulting in an improvement of skin roughness, elasticity, and turgor. 7,8In the same line, PCL-based dermal fillers has shown a collagen formation around PCL particles even after 13 months and also were proven to remain present in a histological examination 2 years after being applied to the dermis. 7,8As for PCL threads, they showed a higher amount of collagen type III formation at 4 weeks and a significantly higher overall collagen formation at 8 weeks compared to F I G U R E 1 Skin adverse effects such as redness, uneven skin tone, skin sensitivity, parts blotchy, parts not smooth, tightness, itching, parts scarred, burning recorded a week after the procedure in the group treated with P(LA/CL) threads with HA (A) and in the group treated with P(LA/CL) threads without HA (B).PDO and PLLA threads. 17Adding to that, a prolonged lifting effect of PCL-barbed threads has also been reported compared to PDO and PLLA ones. 17 Lately the P(LA/CL) threads (75% polylactic acid and 25% polycaprolactone) in which a bidirectional type of barbs was used to increase tissue fixation and subsequently better tissue integration in addition to the lifting effect have been developed followed by the new generation lifting threads where a HA was added to coat the P(LA/CL).HA is a biodegradable non-immunogenic and non-toxic glycosaminoglycan and an essential component of the extracellular matrix.Approximately half of the total HA in the body is present in the dermis 18 maintaining and also regulating the skin and connective tissue hydration. 19In addition, HA showed an ability to stimulate elastin and collagen, fasten wound healing, and also reduce inflammation.Recent reports have worthfully proven the safety and high efficacy of HA in aesthetic treatment. 19e recent comparative study by El-Mesidy et al. evaluated the efficacy of HA cheek filler injection vs. thread lifting in regards of improving the nasolabial folds, reporting statistically significant improvement in GAIS favoring the filler. 20Although fillers are recommended for patients with sagged thin face, an argument about the benefits of threads for patients desiring an oval, less wide face shape is also proven. 20Of note, several reports suggest that the best visual appearance is reached by combining fillers and threadlifting. 21,22wever, the concomitant application of two procedures, each having notable side effects at a recovery period, limits the demands and satisfaction with such The new product of lifting threads which contains HA deserves reasonable attention as it combines two techniques in one procedure.

Face-Q was
filled by the patient before and 4 and 12 months after the procedure.The early recovery symptoms and skin adverse effects (Redness, Uneven Skin Tone, Skin Sensitivity, Parts Blotchy, Parts Not Smooth, Tightness, Itching, Parts Scarred, Burning) were recorded 1 week after the procedure during patient's first follow up visit.Additionally, the 5-point Global Aesthetic Improvement Scales (GAIS) were provided independently by patients themselves and by two physicians, − the principle investigator and another aesthetic practitioner, 4 and 12 months after the treatment.The score of 1 refers to an exceptional improvement, the score of 2-a very improved patient, 3-an improved patient, 4-unaltered patient, and 5-worsened patient.

2. 4 |
Photography settings All patients accepted the reproduction of their recognizable photographs.The photographic set-up consisted of a tripod (Manfroto tripod, model FB 10 Series 075, 141 RC; Manfrotto Nord SRL, Villapaiera Bl., Italy) that held a camera (Canon, model EOS 80D; Shimomaruko).The tripod controlled the stability and the correct height of the camera according to the subject's body height-this ensured the correct horizontal position of the optical axis of the lens (Macro Canon lens 18-135 mm).A primary flash was also attached to the tripod at a distance of 27 cm from the optical axis of the camera and 75 degrees from the upper right angle to avoid the 'red-eye effect' on the photographs.

2
Intragroup difference in FaceQ data from the baseline to 4 months (A), from the baseline to 12 months (B) and from 4 to 12 months (C) in the groups treated with P(LA/CL) threads with HA.

TA B L E 3
Intragroup difference in FaceQ data from the baseline to 4 months (A), from the baseline to 12 months (B) and from 4 months to 12 months (C) in the groups treated with P(LA/CL) threads without HA.

F I G U R E 2
The results of our study showed a significant long term clinical improvement reported by patients through the FaceQ after being treated with the P(LA/CL) threads with or without HA as far as age appraisal, psychological function, satisfaction with the overall facial appearance and skin appearance, appraisal of nasolabial folds, and satisfaction with the lower face and jaw aspects.Importantly though, P(LA/CL) threads with HA showed pronounced long term effects in skin satisfaction and improvement of lower jaw and face.GAIS scale reported by two physicians also indicated better improvements in patients administered with HA-containing threads in a long run.Of outmost importance, treatment with HA-coated threads has boosted recovery period by reducing the skin adverse effects such as skin redness, uneven tone, irregular surface, burning, and itching sensation.Shorter and easier recovery is an overall goal for choice of minimally invasive treatment procedures.Photographs of the patients before and 12 months after facial thread lifting using P(LA/CL) threads with HA.This study reports for the first time the added value of the HA to P(LA/CL) lifting thread in terms of lasting satisfaction and minimized adverse effects of treatment.Nevertheless, the limitations of the study should be acknowledged and may become a focus for future research.First, its retrospective nature mainly limits the interpretation of the adverse effects results.Second, the small sample size lessens the feasibility of drawing conclusive clinical outcomes.Third, the subjective information provided by both patients and physicians create the bias in the evaluation of the procedure outcomes.This study, however, opens avenues to further larger scale research to establish the clinical benefits of including HA in the barbed threads manufacturing for more satisfactory face rejuvenation outcomes.AUTH O R CO NTR I B UTI O N S Georges Ziade conceived the idea and supervised the study.Georges Ziade, Dayane Daou, Desiree Karam and Murat Tsintsadze collected and analyzed the data.Georges Ziade and Dayane Daou wrote the manuscript.How to cite this article: Ziade G, Daou D, Karam D, Tsintsadze M. The third generation barbed lifting threads: Added value of hyaluronic acid.J Cosmet Dermatol.2024;23:186-192.doi:10.1111/jocd.15885TA B L E 5 Intergroup difference in GAIS provided by patients and two physicians in the groups treated with P(LA/CL) threads with HA versus P(LA/CL) threads without HA.

Baseline-4 months Variable Mean difference p Value
(A)Note: Bold values p < 0.05 means statistical significance.

(A) Baseline-4 months Variable Mean difference p Value
Intergroup difference in FaceQ data from the baseline (A), at 4 months (B) and at 12 months (C) in the groups treated with P(LA/CL) threads with HA versus P(LA/CL) threads without HA.
TA B L E 4