Clinical Study on Facial Rejuvenation of Non-crosslinked Small Molecule Hyaluronic Acid Combined with Filorga NCTF®BOOST135 HA

He LIU,Qin-bao HU,Qiang YUAN

1 Department of Medical Beauty,Beijing Sixth Hospital,Beijing City.100007,China;

2 Gansu Vaccine Engineering Technology Research Center of Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou City,Gansu Province,730046,China

ABSTRACT Objective To observe the clinical application of non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®BOOST135HA in facial rejuvenation.Methods A total of 156 patients were selected from the outpatient department of our department from January 2017 to January 2018,including 36 males and 120 females.They were randomly divided into treatment group (82 cases) and control group (74 cases).The age of the treatment group was 25-50 years old,with an average age of 34 years old,while that of the control group was 26-48 years old,with an average age of 35 years old.group A was treated with non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®BOOST135 HA,while group B was treated with non-crosslinked small molecule hyaluronic acid alone.Through two methods,the facial skin state is analyzed and the therapeutic effect is evaluated.Results Follow-up for 3-6 months after treatment showed that 73 cases were satisfied and 9 cases were not satisfied in group A,with a satisfaction rate of 89.02%.In group B,52 cases were satisfied and 22 cases were dissatisfied,with a satisfaction rate of 70.27%.Conclusion Hyaluronic acid combined with Filorga NCTF®BOOST135 HA is better than hyaluronic acid alone in the treatment of facial rejuvenation,and patients obtain higher satisfaction.

KEY WORDS Non-crosslinked small molecule hyaluronic acid;Filorga NCTF®BOOST135 HA;Electronic syringe

With the growth of age,the moisture in people’s skin and soft tissues gradually decreases,the problems of dry skin,wrinkles,color spots,large pores and the like become increasingly serious,and the face tends to age.Facial rejuvenation (including appearance,anatomy and physiological structure,etc.) is a variety of treatment methods that can restore the youthful appearance of aged facial skin.Therefore,facial rejuvenation technology is particularly important among the female masses.Effectively relieving facial aging,solving dry skin and anti-aging are the problems that need to be solved urgently in clinical plastic surgery［1］.At present,domestic antiaging technologies mainly include laser cosmetology,injection cosmetology and surgical cosmetology.Among them,laser cosmetology and injection cosmetology takes short operation time,has fast recovery time and little trauma,which are highly sought after by the majority of beauty lovers.Non-crosslinked small molecule hyaluronic acid (Huaxi Frida Biomedical Co.,Ltd.,batch number:1640038),Filorga NCTF®BOOST135 HA (Jiaxi (Beijing)Biomedical Co.,Ltd.,batch number:W65110731) and other drugs are injected into skin through electronic syringe (Derma Shine,Beijing Linte Pharmaceutical Co.,Ltd.),i.e.Hydro-phototherapy,which is a popular microplastic therapy method in recent years.The mechanism is that non-crosslinked small molecular hyaluronic acid and Filorga NCTF®BOOST135 HA are uniformly injected into the dermis of skin through an electronic injector.The non-crosslinked small molecule hyaluronic acid is hydrophilic and binds to water molecules,and Filorga NCTF®BOOST135 HA has the functions of binding to water molecules to promote the discharge of metabolic wastes and pigments to achieve the effects of improving skin texture,nourishing skin and resisting aging.In this study,the two drugs were combined to explore their clinical therapeutic effects.

INFORMATION AND METHODOLOGY

General data are selected from 156 outpatients from January 2017 to January 2018.They were randomly divided into treatment group (group A) with 82 cases,including 16 males and 66 females.There were 74 cases in the control group (group B),including 14 males and 60 females.The age of the treatment group was 25-50 years old,with an average age of 34 years old,while that of the control group was 26-48 years old,with an average age of 35 years old.The skin types were all Fitzpatrick[2]skin grade II-V.In group A,there were 15 cases of male type V,1 case of type III,6 cases of female type IV and 60 cases of type II.In group B,there were 4 cases of type V,10 cases of type III,10 cases of type III and 50 cases of type II in males,and 10 cases of type III and type II in females.There was no significant difference in the general data between the two groups (P >0.05),which was comparable.

Inclusion criteria:dry facial skin,fine lines,dark skin color,excessive oil secretion,pigmentation,bulky pores,etc.

Exclusion criteria:(1) Pregnant women and breastfeeding patients;(2) Patients with skin tumors and active skin diseases;(3) Patients with acute infection in the treatment area;(4) Patients with mental illness;(5)Those who expect too much and unrealistic treatment;(6) There are metal implants in the treatment area;(7)Patients equipped with cardiac pacemakers and automatic defibrillators;(8) Patients with infectious diseases (e.g.Hepatitis B);HIV);(9) Allergic to hyaluronic acid.

TREATMENT METHOD

Treatment principle:The technical principle of electronic syringe (water needle technology) is to suck up the skin by circulating negative pressure,and at the same time insert a plurality of hollow microneedles into a specific layer of the skin to inject nutrients or drugs,then the negative pressure disappears,and the syringe is automatically separated from the skin.[3]

Preparation before treatment ① Clean facial skin;(2)Inquire about the medical history in detail;(3) Take photos at a distance of 1 meter from the patient and collect relevant materials;sign the informed consent form for treatment;④ Surface anesthesia:Apply a proper amount of lidocaine cream (2.5% lidocaine2.5% procaine,Beijing Ziguang Pharmaceutical Co.,Ltd.)to the face evenly,and cover it with a disposable plastic mask,apply the anesthetic for 40 minutes,and wipe the anesthetic clean.

Facial disinfection before treatment ① Disinfect the electronic syringe handle,operation interface,buttons,disposable negative pressure tube and other parts in contact with skin with 75% medical alcohol.② Disinfect the face with iodophor,and decolorize it twice with 0.9% aseptic normal saline after disinfection for 3 times.Negative pressure catheter and aseptic injection needle are disposable items.

Treatment process:① Turn on the switch of the electronic syringe,check whether the instrument is running abnormally,and set the parameters:Auto-Sensing mode;Power Lv:8;Pause Lv:5.(2) Connect the injection handle and the injection needle.(3) Install the syringe on the handle of the electronic syringe,connect the disposable aseptic injection needle and the negative pressure tube,and push the syringe to check whether each needle is unobstructed and whether the medicine is discharged evenly.Adjust the injection depth according to the patient’s skin state,and it is advisable to have needle-like bleeding.Observe the patient’s reaction at any time during the injection.Excessive injection level can cause ecchymosis and pain.The injection is too shallow to achieve the therapeutic effect.The single injection dose was 0.0312-0.05 m1.④In group A,2ml of noncrosslinked small molecular hyaluronic acid and Filorga NCTF®BOOST135 HA3ml were injected into the dermis after uniformly mixing through disposable sterile medical three-way;Patients in group B were injected with 2ml of non-crosslinked small molecule hyaluronic acid alone.The treatment parameters and single injection amount of the two groups were the same.

Treatment course and follow-up:Both groups of patients were treated 4 times with an interval of 1 month.After the treatment,the patients were followed up for 1 week,1 month,3 months and 6 months to investigate the postoperative effect and satisfaction.

Curative effect judgment:VISIA skin detector (Canfield Company ,USA) was used to detect the patients’ faces.The detection includes three physiological indexes:color spots,wrinkles and pores.The score generated by the detector is used as the analysis standard.The score represents the area where the skin feature detection value appears in the selected area.Healing:wrinkles,large pores,flabby skin,dark skin color,pigmentation improvement area >80%;Remarkable effect:the area is improvedby 50%-80%;Improvement:20%-50%ofthe improvedarea;Ineffective:improvement area<20%[4].The effective rate = (curemarkedly effective)/number of cases in this group× 100%,and the total effective rate= number of satisfactory cases/total number of cases×100% in both combinations.

RESULTS

Test results of VISIA skin tester:156 patients were followed up for 3 to 6 months after 4 treatments,The test results of VISIA skin tester were analyzed by SPSS17.0 statistical software,and the data were expressed in the form of xs.The results of t test showed that there were significant differences in skin pores,wrinkles and color spots before and after treatment,regardless of whether the single drug (group B) or the combined drug (group A),indicating that the effect before and after treatment was obvious (P <0.01).At the same time,comparing group A with group B,the above three test items also have extremely significant differences (P <0.01),indicating that the combined medication effect of group A adopted in this study is better than that of group B single medication,as shown in Table 1.

Therapeutic effect:In group A,73 cases were satisfied with the therapeutic effect (70 cases were cured and 3 cases were markedly effective),while 9 cases were ineffective as they were not satisfied,with an effective rate of 89.02%;In group B,52 cases were satisfied (50 cases were cured and 2 cases were markedly effective),while 22 cases were ineffective as they were not satisfied,with an effective rate of 70.27%.The total effective rate was 80.13%.SPSS17.0 statistical software was used for analysis.X2 test showed that X2=8.59,P <0.05.The clinical therapeutic effects of the two groups were statistically significant.Group A (non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®BOOST135 HA) had better a therapeutic effect on facial skin aging than group B (non-crosslinked small molecule hyaluronic acid alone),and the patients obtained higher satisfaction,as shown in Table 2.

Adverse reactions

In the two groups of patients,some patients had obvious pain and ecchymosis occurred around the needle eye within 24 hours after the operation.The ecchymosis gradually disappeared 72 hours after cold compress.

Tab.1 The results of VISIA skin detector (x±s)

Tab.2 The comparison of treatment effect between two groups patients

Typical cases

The patient in the treatment group,Mrs.Wang,female,30 years old,felt dry skin and had obvious wrinkles for 1 year with no treatement.Scattered brown freckles of different sizes can be seen on zygomatic and cheek.Fine lines were formed on the skin of bilateral outer canthus.The patients were treated with non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®135 HA for the first time.The skin color turned yellow on the 3rd day after treatment and no special treatment was given.Follow-up was continued.One week after treatment,the patient returned to the clinic,and the skin yellowing disappeared.She felt that the symptoms of skin dryness were relieved,the glossiness was increased,the freckles on zygomatic and cheek became lighter,and the fine lines on both sides of outer canthus partially disappeared.According to the course of treatment,the treatment continued without yellowing of skin and the treatment effect was satisfactory.

DISCUSSION

Facial skin aging is one of the common clinical manifestations of body aging,and its causes are related to ultraviolet radiation in sunlight.Ultraviolet rays can lead to degradation of skin collagen fibers,abnormal deposition of elastic fibers and loss of moisture in dermis.The main manifestations are facial skin elasticity reduction,relaxation,dryness,subcutaneous soft tissue atrophy,wrinkle formation,etc.[5].The water content in the dermis layer of skin is inversely proportional to age.With the increase of age,the water content in the dermis layer gradually decreases,while the structural abnormalities of collagen fibers and elastic fibers lead to the decrease of skin elasticity.Therefore,how to improve skin elasticity,increase moisture,fade wrinkles and other technologies have attracted the attention of clinicians.Electronic syringe,i.e.Water needle technology,has been widely used in the country since 2015 and is one of the clinical methods to treat facial skin aging.Non-crosslinked small molecule hyaluronic acid and Filorga NCTF®BOOST135 HA can improve the static fine wrinkles of facial skin,reduce pores and increase skin elasticity.The small wound surface caused by the injection needle on the skin can also stimulate the regeneration and repair function of the skin,repair the structure of elastic fibers and collagen fibers and increase their content,and finally achieve the effect of delaying skin aging[6-7].

Non-crosslinked small molecule hyaluronic acid regulates the water balance in tissues through its hydration[8].In addition,non-crosslinked small molecule hyaluronic acid has high hydrophilicity and can absorb a large amount of water due to its special molecular structure.2% pure hyaluronic acid aqueous solution can combine 98% water,which can lock water and keep moisture,maintain good elasticity of skin,and also keep skin smooth[9]However,with the increase of age,the content of hyaluronic acid in the human body gradually decreases,and the moisture in the skin is lost,thus causing skin aging and wrinkle formation.According to the hydrophilicity of hyaluronic acid,non-crosslinked small molecule hyaluronic acid was injected into dermis in this experiment.Due to its unique molecular structure,the occurrence rate of adverse reactions is low,and good clinical therapeutic effects can be achieved in improving facial wrinkles and dry skin[10-11].Therefore,the use of non-crosslinked small molecule hyaluronic acid to supplement the content of hyaluronic acid in skin can increase the water absorption of tissues and improve the aging of facial skin[12].

Filorga NCTF®BOOST135 HA was developed by the Filorga Laboratory in France.It is based on the biological structure of embryonic stem cells.Its main components contain high concentration of hyaluronic acid,glutathione,12 vitamins,6 coenzymes,6 minerals,5 nucleic acids,1 antioxidant and 23 amino acids.Filorga NCTF®BOOST135 HA landed in China in 2016 and was used clinically.High concentration hyaluronic acid combined with non-crosslinked small molecule hyaluronic acid plays a superposition role,which can nourish skin,increase skin elasticity and glossiness,and delay aging.The skin color of human body is mainly determined by melanin[13-15].Vitamin C among the 12 vitamins can affect the activity of tyrosinase,which is the catalyst for tyrosine conversion into melanin and the main rate-limiting enzyme in melanin production,and plays a key role in melanin production.Vitamin C can inhibit the formation of melanin,promote metabolism and resist oxidation,thus whitening skin color[16].The loss of antioxidants is one of the causes of facial skin aging,because it can prevent and repair skin aging caused by free radicals.Therefore,the injection of Filorga NCTF®BOOST135 HA into the dermis of skin can appropriately supplement skin antioxidants and play a role in delaying aging.Glutathione,amino acids and other nutrients can promote the discharge of metabolic wastes and pigments.Filorga NCTF®BOOST135 HA can reduce water loss in skin,promote blood circulation,stimulate cell growth,increase collagen and elastic fiber content in skin,promote skin tissue reorganization and cell self-repair,and increase skin elasticity,thus effectively improving skin problems such as skin relaxation,skin dryness,fine lines,pigmentation,etc.and achieving antiaging therapeutic effect.

Fig.1 Typical cases from Group A

CONCLUSION

Non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®BOOST135 HA is better than non-crosslinked small molecule hyaluronic acid alone in the treatment of facial skin aging,and patients obtained higher satisfaction.