Observation on clinical effect of botulinum toxin type A injection combined with low-energy CO2fractional laser periocular rejuvenationtreatment

Mei-lian ZHENG,Guang-min LIN,Yi-yan TANG

Department of plastic surgery,Zhangzhou Municipal Hospital,Zhangzhou City,Fujian province,363000,China

ABSTRACT Objective To investigate the clinical effect of botulinum toxin type A injection combined with low-energy CO2 fractional laser periocular rejuvenation treatment.Methods The clinical effect of botulinum type A injection alone and botulinum type A injection combined with low-energy CO2 fractional laser was compared in 96 patients who needed to receive periocular rejuvenation treatment from April 2018 to April 2019.Results After the combined low-energy CO2 fractional laser treatment was given on the basis of botulinum toxin type A injection,the follow-up global aesthetic improvement scal（eGAIS）scores of the observation group were 86.78 4.67,80.31 3.66,76.94 4.03 and 40.59 4.78.The global aesthetic improvement of the dynamic and static wrinkles was obvious.The total effective rate was 93.7%.The total satisfaction rate of the patients was 95.8%,which was higher than that of the control group（ P <0.05).The clinical efficacy was significant.Conclusion The application of the combined periocular rejuvenation treatment can improve the dynamic and static wrinkles simultaneously with remarkable rejuvenation effect,increase the effective rate of treatment and enhance the patients' satisfaction.

KEY WORDS Botulinum toxin type A injection;CO2 fractional laser;periocular rejuvenation;wrinkle;clinical effect;satisfaction

There is a great demand in modern life to improve the dynamic and static wrinkles around the eyes by periocular rejuvenation treatment.At present,botulinum toxin type A injection is widely used in the treatment of facial wrinkles,which can significantly improve the cosmetic effect of dynamic wrinkles,but its effect on improving static wrinkles is not obvious,and the treatment is limited because the injection site is in sensitive areas such as periocular area[1].The low-energy CO2fractional laser is characterized by strong penetration,which can directly pass through the skin to the dermis,contract the collagen fibers in varying degrees,smooth the small wrinkles,fade the deep wrinkles to realize the cosmetic effect of tightening and rejuvenating the skin[2].In this study,96 patients who needed to receive periocular rejuvenation treatment in our hospital from April 2018 to April 2019 (observation time was 6 months)were analyzed to compare the clinical effect of botulinum toxin A injection alone and botulinum toxin A injection combined with low-energy CO2fractional laser.Now ,the study results are reported as follows.

MATERIALS AND METHODS

General material

96 patients who needed to receive periocular rejuvenation treatment from April 2018 to April 2019 were selected as the subjects of this study.The patient’s living conditions were stable for at least 6 months;they could strictly follow the doctor’s instructions to come to the hospital for reexamination;they voluntarily accepted this study and could complete the follow-up on time;they were all free of mental illness;they had passed the examination and approval of the hospital ethics committee and signed the informed consent[3].Exclusion criteria[4]:Patients who had excessive requirements for treatment effect;patients who had pregnancy preparation plan within 6 months or those who were breastfeeding their baby recently ;patients who were allergic to experimental drugs (botulinum toxin type A,lidocaine,etc.);patients whose periocular skin was damaged or in active skin disease;patients who had serious infectious diseases or coagulation dysfunction;patients who had received filling treatment such as collagen filling treatment at the injection site within 6 months or those who had received permanent filling treatment such as Artecoll;patients who had been exposed to the sun or strong light within one month.

96 patients were randomly divided into control group and observation group.In the control group,48 patients were treated with botulinum toxin type A injection alone,including 9 male patients and 39 female patients,aged 34-62 years,with an average age of (46.38 ± 5.69);in the observation group,48 patients were treated with combination treatment,including 10 male patients,38 female patients,aged 33-62 years,with an average age of(47.674.57).The two groups were comparable because there were no statistically significant differences in general data such as gender and age (P >0.05).

Methods

The control group was treated with botulinum toxin type A injection alone,and the observation group was treated with botulinum toxin type A injection combined with low-energy CO2 fractional laser.The specific steps are as follows.

InstrumentThe CO2fractional laser therapeutic apparatus is Kinglaser KL CO2fractional laser therapeutic apparatus.The laser wavelength is 10600nm,the output energy is 10～160mJ,the output power range is 1～25W(adjustable).The laser emission mode includes continuous output,single pulse,repetitive pulse,super pulse and so on.

CO2 fractional laser treatmentTreatment area was divided into upper eyelid,lower eyelid,crow’s feet and other areas according to the wrinkles around the patients’ eyes.Before treatment,the patients were anesthetized locally and sterilizeXXXXXd regularly to prevent infection.120 hand tools were used for operation,the output energy was set at 25-50mJ,the output power was adjusted to 20W,the light spot coverage rate was 9% and the degree was 2,and it was evenly hit in the treatment area.If the wrinkles in the treatment area were relatively obvious,the operation was repeated for 1-2 times.After the fractional laser treatment,the treatment area should be continuously coated with antibiotic ointment (such as erythromycin ointment,SFDA approval number H34020379,Front Pharmaceutical PLC.) for anti-infective treatment for at least 3 days and 2 times /day;the treatment area was covered with ice within 24 hours;the treatment area should be kept away from water within 2 days,and the disinfectant facial mask was applied to the treatment area according to the patient’s condition of laser treatment to make the scab fall away early;for 3 months,attention should be paid to sun protection,direct sun exposure should be avoided,and sunscreen or sunglasses should be used if necessary.

Botulinum toxin type A injectionBotulinum toxin type A was injected into two groups of patients.Each bottle of botulinum toxin type A (SFDA approval number 10970037,Lanzhou Institute of Biological Products) for injection contains 100u botulinum toxin type A .The injection method was standard injection,and the injection sites were forehead wrinkles,glabellar wrinkles,crow’s feet,etc.The injection points of botulinum toxin type A(5-7 points in forehead wrinkles,3-5 points in glabellar wrinkles and 3-6 points in crow’s feet) were determined by expression wrinkles.30 minutes before the treatment,5% compound lidocaine cream(SFDA approval number H20063466,Beijing Ziguang Pharmaceutical Co.,Ltd)was evenly applied to the area around the eyes that needed to be treated.The 100UA botulinum toxin type A was diluted in 2.0ml normal saline,which was injected subcutaneously with 30G needle at a fixed point,and the injection volume was 2-4u at each point.After the injection,the injection site was pressed for 3-5min to avoid congestion and swelling.

Combination treatmentThe observation group was given the combined treatment.30 minutes before the treatment,5% compound lidocaine cream (gyzzh20063466,Beijing Ziguang Pharmaceutical Co.,Ltd.) was evenly applied to the area around the eyes that needed to be treated.The low-energy CO2 fractional laser treatment was performed first,followed by ice compress for 10-15 minutes,and then the botulinum toxin A injection was conducted.After treatment,the patients were observed for 20-30min,and normal life could be achieved if there was no abnormality.1.2.5 Precautions Patients were told to take effective measures for sun protection as much as possible to avoid pigmentation in direct sunlight;the time needed for reexamination and follow-up is informed to the two groups of patients,which were 7 days,1 month,3 months and 6 months after treatment.The patients should arrange their living and working time reasonably,reexamine the treatment effect in time,keep the contact way unblocked,cooperate well with the follow-up and ensure the authenticity of the effect.

Observation index and evaluation standard

The wrinkle recovery degree,treatment effective rate,effect evaluation and patient satisfaction after the treatment with botulinum type A injection alone and botulinum type A injection combined with low-energy CO2 fractional laser were compared between the two groups to evaluate the treatment effect.

According to global aesthetic improvement scale (GAIS)scores ,there are 5 grading scores[5]:deterioration (-1),ineffectiveness (0),slight improvement (1),obvious improvement (2),complete improvement (3).

The patient’s wrinkle degree is evaluated by wrinkle severity grading scale(WSRA)[6]:Level I:no wrinkles,only continuous skin lines;level II:slight indentation,and visible small wrinkles on the face;level III:deep folds,and clearly visible facial wrinkles;level IV:long and deep wrinkles,obvious wrinkles,less than 2mm visible wrinkles when stretched;Level V:obvious long and deep wrinkles,detrimental to facial appearance,2-4mm visible wrinkles wxhen stretched.The effect evaluation is divided into obvious effectiveness,effectiveness and ineffectiveness:obvious effectiveness:after treatment,the wrinkles degree is reduced by at least 2 levels;effectiveness:after treatment,the wrinkles degree is reduced by 1 level;ineffectiveness:the level is basically unchanged before and after treatment[7].

The hospital’s self-designed satisfaction questionnaire was used.The full score is 100.A score above 95 indicates great satisfaction,a score above 90 indicates satisfaction,and a score below 90 indicates dissatisfaction.

Statistical method

The data were analyzed by SPSS18.0 system software,the counting data were expressed by (n,%),and tested by x2;the measurement data were expressed by (x±s),and tested by t;P <0.05,indicating statistical significance..

RESULTS

Comparison of GAIS scores between the two groups

After the combination treatment,the GAIS scores of dynamic and static wrinkles in the observation group were higher than those in the control group (Fig.1),as shown in tables 1-3.

Comparison of treatment effective rate between the two groups

After the combination treatment,the total effective rate of the observation group is higher than that of the control group,as shown in Table 4.

Fig.1 Comparison before and after 1 month after the botulinum toxin type A combine with fractional laser treatment

Comparison of patients’ satisfaction between the two groups

The satisfaction of the observation group is significantly higher than that of the control group (P<0.05),as shown in Table 5.

DISCUSSION

At present,the development trend of non-surgical facial beauty treatment is to combine multiple methods,such as soft tissue filler injection,botulinum toxin injection,laser skin rejuvenation and chemical skin replacement,so as toachieve better cosmetic effect[8].

Table 1 GAIS score of dynamic and static wrinkles in the control group

Table 2 GAIS score of dynamic and static wrinkles in observation group

Botulinum toxin is a neurotoxin that irreversibly blocks the release of acetylcholine in the presynaptic area,which has been successfully used in the treatment of facial spasm,such as blepharospasm,strabismus and focal dystonia[9].At the same time,it is also used in the treatment of glabellar wrinkles,and its indications have been extended to almost all facial wrinkles,including crow’s feet,forehead wrinkles,etc.[10].However,it has little effect on static wrinkles caused by skin elasticity and texture change,and only has effect on dynamic wrinkles.In addition,its injection site also has certain limitations,its injection in the lower eyelid area may cause some problems,such as facial and baggy eyelids relaxation.Therefore,after it is injected into the skin around the eyes,the residual wrinkles on the face become a difficult problem in the treatment[11].

The wavelength of the gradually developed CO2fractional laser is 10600nm,which is easy to be selectively absorbed by the water in the skin,resulting in superficial skin exfoliation and dermal microthermal injury to achieve the effect of young and compact skin[12].The CO2fractional laser can directly penetrate the dermis to make wrinkles or other skins damaged and gasified ,and stimulate the proliferation of collagen in the dermis to start a series of wound healing responses such as tissue repair and collagen rearrangement[13].Because the collagen fiber shrinks under the action of laser,the fine lines will be flattened,the deep lines will become thinner and thinner,and the skin will become tight and glossy[14].

Therefore,CO2fractional laser is the first choice to treat the static wrinkles and improve the texture of the periocular skin.For light fine lines,photoelectric treatment can stimulate the skin to produce new collagen and rearrange it,and botulinum toxin can reduce the muscle tension under the skin,reduce the activity and furtherpromote the arrangement of new collagen to make the skin heal in a wrinkle-free manner after laser treatment,thereby producing smooth skin to effectively prevent the recurrence of wrinkles[15].For severe wrinkles,botulinum toxin combined with other methods also has a good effect,the cosmetic effect is obvious.Botulinum toxin injection can significantly reduce dynamic wrinkles,fractional laser has a better effect on static wrinkles,botulinum toxin combination treatment and other methods have a good effect and satisfaction rate[16].In this study,the combined low-energy CO2fractional laser treatment was given on the basis of botulinum toxin type A injection.After the timely reexamination and follow-up ,the GAIS scores of the observation group at 7 days,1 month,3 months,and 6 months after treatment were 86.784.67,80.313.66,76.944.03,and 40.594.78,which further confirmed that the overall cosmetic effect of dynamic and static wrinkles was improved significantly at 1-3 months.The total effective rate was 93.7%,which was higher than 73.0% of the control group.,indicating that the treatment effect was obvious.The total satisfaction rate of patients was 95.8%,which was higher than 85.4%of the control group (P <0.05),showing that the clinical effect was obvious.Yalici-Armagan and Basak et al.[17]carried out the facial rejuvenation treatment in 29 patients for 3 months and achieved good results.Zhu j et al.[18]performed the botulinum toxin type A combined with CO2fractional laser facial rejuvenation treatment in 20 female patients,the cosmetic effect is obvious ,the satisfaction of the observation group injected with botulinum toxin was significantly higher than that of the control group injected with normal saline,and the overall score was improved.The above study shows that facial rejuvenation treatment has changed from single to comprehensive treatment,but there are relatively few clinical studies on Asian skin.This is also a small sample prospective study,which requires a large number of randomized controlled trials to verify the results.The botulinum toxin type A injection combined with low energy CO2fractional laser periocular rejuvenation treatment given to the patient can improve the dynamic and static wrinkles simultaneously with significant skin rejuvenation effect,increase treatment effective rate and enhance the patient’s satisfaction .We suggest that the botulinum toxin type A injection can be used as adjuvant treatment after CO2laser treatment,and the way to optimize its clinical effect is still worthy of further study.

Table 3 Comparison of GAIS scores between the two groups (x±s,score)

Table 4 Comparison of treatment effective rate between the two groups [n (%)]

Table 5 Comparison of patients’ satisfaction between the two groups [n (%)]