| Bcckground:Rosacea is a chronic inflammatory disfiguring skin disease with a variety of clinical manifestations,the main and most important clinical manifestations of which are paroxysmal facial flushing and persistent erythema,often accompanied by embarrassment,low self-esteem and anxiety,which have a significant impact on the patient’s quality of life.The prevalence of the disease is high,with an average international prevalence of 5.46% according to the latest meta-analysis of epidemiological data across international populations.Despite the variety of treatments available,the effect are limited and prone to recurrence,and flushing and persistent erythema are still common problems that plague patients and clinical care,and new or better treatments need to be found.Previous literature and clinical observations have shown that intradermal injections botulinum toxin type A(BTX-A)significantly improve flushing and persistent erythema in patients with rosacea,with a low and mild incidence of adverse effects.To date,the same dilution concentration of BTX-A solution has been used in a report,and no study has been conducted to compare the differences in treatment with different concentrations of BTX-A.Therefore,this study was conducted to compare the efficacy and safety of different concentrations of BTX-A by microdroplet intradermal injection in the treatment of rosacea,in order to find a better solution with botulinum toxin injections in the treatment of rosacea.Objective:To compare the efficacy and safety of different concentrations of botulinum toxin type A microdroplet intradermal injections in rosacea.Methods:Forty-seven patients who met the criteria for rosacea and were randomly divided into control group(Group A,n=25)and experimental group(Group B,n=22)according to the random number table method were selected to attend the Dermatological and Cosmetic Center of Henan Provincial People’s Hospital.Two groups received oral medication(doxycycline hydrochloride combined with hydroxychloroquine sulfate),and the experimental group was given BTX-A intradermal injection on top of oral medication.Patients in group B were randomly divided into group B1 and group B2 on both cheeks,and group B1 received 1 U/0.1 m L of BTX-A intradermal injection and group B2 received 2 U/0.1 m L of BTX-A intradermal injection.Efficacy observations were performed before and 2,4,and 12 weeks after treatment,including Global Flushing Severity Score(GFSS),Clinician Erythema Assessment scale(CEA),and non-invasive quantitative skin tests,The tests included Transepidermal waterloss(TEWL),Erythema index(EI),stratum corneum water content,sebum content,and Rosacea Quality of Life Index(Rosa Qo L)scores.The pain associated with the injection was recorded using visual analogue scale(VAS)after the injection treatment.The presence or absence and severity of the following adverse reactions were recorded during the follow-up: such as allergic reaction,bruising,exacerbation of erythema,edema,muscle weakness,dysphagia,dry mouth,dysphonia,gastrointestinal discomfort(nausea,vomiting),dry eyes,dizziness,etc.SPSS 25.0 software was applied for statistical analysis of the recorded data.Results:A total of 47 patients were included in both groups,44 patients completed treatment and follow-up,23 patients completed follow-up in group A(2 cases missed)and 21 patients completed follow-up in group B(1 case with imperfect follow-up information).age in group A ranged from 23 to 42 years,mean(30.35±4.69)years,group B ranged from 24 to 42 years,mean(32.76±5.58)years;duration of disease in group A ranged from 18 to 35 months,mean(26.74±4.55)months,group B ranged from 21 to 32 months,mean(26.95±3.57)months.mean(26.74±4.55)months,and group B had a duration of illness from 21 to 32 months,mean(26.95±3.57);the age,duration of illness,GFSS,CEA,TEWL,EI,stratum corneum water content,sebum content,and Rosa Qo L score were compared among the groups and were consistent at baseline,with no statistically significant differences(P>0.05).1.Within-group comparison: compared with week 0,GFSS,CEA,and TEWL were significantly lower in group A at 12 weeks(P<0.05),and GFSS,TEWL,EI,stratum corneum water content,and sebum content were significantly improved in groups B1 and B2 at 2,4,and 12 weeks(P<0.05);compared with 2 weeks,TEWL,EI,stratum corneum water content,and sebum content were significantly improved in groups B1 and B2 at 4 weeks.TEWL,EI,stratum corneum water content and sebum content were significantly improved in groups B1 and B2 at 4 weeks compared to 2 weeks.It was concluded that(1)BTX-A microdroplet injections combined with oral medication and single oral medication are effective in the treatment of rosacea;(2)significant effects were observed at 2 weeks with BTX-A microdroplet injections in combination with oral medication for rosacea,with a significantly faster onset of action than with a single oral medication;(3)BTX-A microdroplet injection combined with oral medication for rosacea is still improving significantly at 4 weeks;and(4)BTX-A microdroplet injection combined with oral medication for rosacea lasts up to 12 weeks.2.Comparison between groups: TEWL,EI,and stratum corneum water content were significantly better in groups B1 and B2 at 2,4,and 12 weeks than in group A(P<0.05),and GFSS,CEA,and sebum content were significantly better in groups B1 and B2 at 2 and 4 weeks than in group A(P<0.05).BTX-A microdroplet injection in combination with oral medication is significantly better than single oral medication in the treatment of rosacea.3,Rosa Qo L: At 12 weeks,the Rosa Qo L scores in groups A,B1 and B2 were significantly lower than those at week 0(P<0.05),and the Rosa Qo L scores in groups B1 and B2 were significantly lower than those in group A(P<0.05).It was concluded that(1)BTX-A microdroplet injection combined with oral medication and single oral medication both significantly improved the quality of life of patients;(2)BTX-A microdroplet injection combined with oral medication significantly improved the quality of life of patients with rosacea better than that of single oral medication.4,The duration of VAS scores and adverse effects were significantly higher in group B1 than in group B2(P<0.05).Conclusion:1.Intradermal botulinum toxin type A microdrop injections for rosacea are safe and effective,have a rapid onset of action,improve the patient’s quality of life,and are superior to traditional oral drug therapy.2.At the same total dose,there was no statistical difference in the clinical efficacy of different concentrations(1U/0.1m L and 2U/0.1m L)of botulinum toxin type A.Pain and duration of adverse effects were significantly higher with 1U/0.1m L botulinum toxin type A treatment than with 2U/0.1mL botulinum toxin type A. |
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