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Objective:To evaluate short-term clinical efficacy and safety of a cooling gel containing calcium-based antimicrobial peptide compounds (CAPCS cooling gel) combined with desonide cream in the treatment of atopic dermatitis (AD) in children.Methods:From November 2019 to September 2020, a randomized, double-blind controlled clinical trial was conducted in 60 children with AD enrolled from Department of Dermatology and Venereology, West China Hospital, Sichuan University. The 60 patients were randomly and equally divided into 2 groups: test group treated with topical desonide cream in the morning and evening as well as topical CAPCS cooling gel at noon during the first 3 days of treatment, followed by topical CAPCS cooling gel in the morning, at midday and in the evening for 11 days; control group treated with topical desonide cream in the morning and evening as well as topical CAPCS-free placebo gel at noon during the first 3 days of treatment, followed by topical CAPCS-free placebo gel in the morning, at midday and in the evening for 11 days. The treatment lasted 2 weeks. Finally, 56 AD patients completed the follow-up, and 28 in each group were included into the following analysis. Clinical indices, such as eczema area and severity index (EASI) , visual analogue scale (VAS) , investigator′s global assessment (IGA) and dermatology life quality index (DLQI) , were recorded before, 7 ± 3 days and 14 ± 3 days after the treatment, so were adverse reactions.Results:After 1-week treatment, 1 patient in the test group and 1 in the control group showed response to the treatment, with the response rate being 3.57% in both groups; after 2-week treatment, 12 patients in the test group and 2 in the control group showed response to the treatment, with response rates being 42.86% and 7.14% respectively; there were significant differences in the treatment outcomes between the two groups after 1- and 2-week treatment ( Z = -4.318, -5.474, respectively, both P < 0.05) . There was no significant difference in the EASI, VAS, IGA or DLQI score between the two groups before treatment (all P > 0.05) ; nonparametric Friedman test showed a significant difference in the changing trend of the EASI score over time between the two groups ( χ2 = 45.720, P < 0.05) . Two-way repeated measurement analysis of variance showed a significant difference in the VAS score ( F = 10.738, P = 0.002) , but no significant difference in IGA or DLQI score between the test group and control group after 1-week treatment ( F = 0.066, 0.804, P = 0.135, 0.374, respectively) ; after 2-week treatment, there were significant differences in the VAS, IGA and DLQI score between the 2 groups ( F = 67.313, 38.949, 51.503, respectively, all P < 0.001) . During the clinical study period, 1 adverse event occurred in the test group and control group each, which manifested as tingling or irritating sensation at the topically treated sites, and there was no significant difference in the incidence rate of adverse events between the two groups ( P > 0.05) . Conclusion:Short-term topical application of CAPCS cooling gel combined with desonide cream is effective for the treatment of AD in children, and does not increase the incidence of adverse reactions compared with the placebo.
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Objective To evaluate the efficacy and safety of desonide 0.05％ cream in the treatment of mild to moderate infantile atopic dermatitis (AD).Methods A multicenter,randomized,openlabeled,active-controlled clinical trial was conducted.A total of 120 infants with AD were enrolled from Department of Dermatology,Beijing Children's Hospital,Capital Medical University,Children's Hospital of Chongqing Medical University and Children's Hospital of Fudan University between December 2016 and November 2017.These patients were randomly divided into 2 groups to be topically treated with desonide 0.05％ cream (test group,n =61) and hydrocortisone butyrate 0.1％ cream (control group,n =59),respectively.After the treatment for 1,2 and 3 weeks,the response rate,improvement of eczema area and severity index (EASI) and infants' dermatitis quality of life (IDQOL) were evaluated,and adverse events and reactions were recorded.Statistical analysis was carried out with SAS 9.4 software using confidence interval method and non-inferiority test for the comparison of response rates between the test group and control group,two-sample t test for the comparison of quantitative data between two groups,paired t test for comparing pre-and post-treatment EASI scores and IDQOL scores.If the data were not normally distributed or there was heterogeneity of variance,Wilcoxon rank sum test was used for the comparisons of pre-and posttreatment EASI scores and IDQOL scores before and after the treatment,and chi-square test was used for the comparison of unordered categorical data between the test group and control group.Results At weeks 1,2and 3 after the initial treatment,analysis of the full analysis set (FAS) showed that 46 (86.79％),49(92.45％) and 51 (96.23％) patients in the test group received improvement respectively,and 36 (83.72％),35 (81.40％) and 41 (95.35％) in the control group received improvement respectively.The non-inferiority test showed that the response rate in the test group was non-inferior to that in the control group (non-inferiority boundary value was-0.15).At the baseline,1,2 and 3 weeks,the EASI scores in the test group were 4.57 ± 3.19,0.72 ± 0.89,0.45 ± 0.87 and 0.18 ± 0.40 respectively,and the EASI scores in control group were 4.50 ± 3.29,1.03 ± 1.81,0.62 ± 0.85 and 0.28 ± 0.82 respectively.Paired Wilcoxon rank sum test showed that the EASI scores in the test group and control group significantly decreased after the treatment for 1,2 and 3 weeks compared with those at the baseline (the test group:T =-715.5,-9.4,-715.5,respectively,all P ＜ 0.001;the control group:T =-437.5,-473.0,-472.0,respectively,all P ＜0.001).However,Wilcoxon rank sum test revealed that there was no significant difference in the EASI scores between the two groups at any of the above time points (P ＞ 0.05).Paired Wilcoxon rank sum test showed that IDQOL scores in the test group significantly decreased at the above time points after the treatment compared with those at the baseline (all P ＜ 0.001),while Wilcoxon rank sum test revealed that there was no significant difference in the IDQOL score between the test group and control group (all P ＞0.05).Adverse reactions were observed in 12 (19.7％) patients in the test group,and 10 (16.9％) in the control group,and there was no significant difference in the adverse reactions between the two groups (x2 =0.029,P ＞ 0.05).Conclusion The efficacy of desonide 0.05％ cream in the treatment of mild to moderate infantile AD is equivalent to that of hydrocortisone butyrate 0.1％ cream,so desonide 0.05％ cream can be a treatment option for mild to moderate infantile AD.
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Objective To evaluate the clinical efficacy and safety of compound polymyxin B ointment combined with desonide cream for the treatment of subacute or chronic eczema. Methods A multicenter, randomized, double?blind, parallel?group, controlled clinical study was conducted. Totally, 144 patients with subacute eczema and 144 patients with chronic eczema were enrolled into this study, and both randomly and equally divided into the test group and control group. The test group and control group firstly topically applied compound polymyxin B ointment and its vehicle respectively, then both topically applied desonide cream 3 hours later. The drugs or vehicle were applied twice a day in all the patients. Patients′ symptoms and signs (including degree of itching, inflammation, erosion/exudation and infiltration/thickening, as well as area of target lesions) were evaluated, and the time to onset and duration of itching?alleviating effect were recorded. The clinical efficacy and safety of treatments were analyzed and compared between the test group and control group. Results The total symptom and sign scores significantly decreased to different extents on days 7 and 14 in the test group(subacute eczema patients:6.09 ± 2.78 and 3.68 ± 3.18 vs. 13.44 ± 1.66; chronic eczema patients: 6.56 ± 2.68 and 4.38 ± 3.27 vs. 12.96 ± 1.16)and control group(subacute eczema patients:8.26 ± 3.17 and 5.28 ± 4.05 vs. 13.60 ± 1.75;chronic eczema patients: 8.84 ± 2.90 and 6.25 ± 3.78 and vs. 12.64 ± 1.18)compared with those at baseline. Moreover, the total symptom and sign score of patients with subacute or chronic eczema was significantly lower in the test group than in the control group on days 7 and 14(all P<0.05). A significant increment was observed in the degree of decrease in scores for itch, infiltration/thickening in patients with subacute eczema in the test group compared with that in the control group(all P<0.01), as well as in scores for itch, infiltration/thickening and area of target lesions in patients with chronic eczema in the test group compared with those in the control group (all P < 0.05). In addition, patients with subacute eczema in the test group showed significantly shorter onset and longer duration of itching?alleviating effect than those in the control group(both P<0.05). The time to onset of itching?alleviating effect was also significantly shorter in patients with chronic eczema in the test group than in those in the control group(P<0.000 1), but there was no significant difference in the duration of it between the two groups of patients with chronic eczema. Clinicians and patients were both more satisfied with therapeutic effects in the test group than in the control group(all P<0.05). Conclusions Topical compound polymyxin B ointment can increase the efficacy of topical desonide cream for the treatment of subacute or chronic eczema, especially subacute eczema. Compound polymyxin B ointment also shows a favorable therapeutic effect on itching and infiltration/thickening in patients with eczema.
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Objective To evaluate the efficacy of tacalcitol ointment combined with desonide cream in the treatment of plaque vulgaris psoriasis. Methods Sixty-six patients with plaque vulgaris psoriasis were assigned into combination treatment group and desonide sole treatment group by random digits table with 33 cases each. In combination treatment group, desonide cream was applied 1 time per day in the morning and tacalcitol ointment was applied 1 time per day at night. In desonide sole treatment group, desonide cream was applied twice one day. The therapy for two groups continued for 8 weeks. Results The total effective rate in combination treatment group was 78.79%( 26/33 ), and it was lower than that in desonide sole treatment group [84.85%(28/33)],but there was no significant difference between two groups (P>0.05). The recurrence rate was 25.00% (7/28) in desonide sole treatment group and 11.54% (3/26) in combination treatmentgroup,there was no statistical difference between two groups (P >0.05). There was no serious side effect during observation. Conclusions Tacalcitol ointment combined with desonide cream has no more effective for plaque vulgaris psoriasis than that of desonide cream alone. The combined use of these two drugs could reduce the dosage of steroid and side effect.
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Objective To evaluate the efficacy and safety of 0.05% desonide cream in the treatment of patients with eczema. Methods A randomized, double-blind, multicenter, vehicle-controlled study was conducted. The patients of the study and control groups applied 0.05% desonide cream and vehicle respectively, twice daily for 3 consecutive weeks. The efficacy was determined by measuring the total scores of erythema, erosion, infiltration, papule, exudation/crust, pruritus and the extent of lesions. Results At the end of the 3 weeks study, the total clinical effective rate was 80.8% in the study group,compared to 41.1% in the control group, with a significant difference between the two groups (P