| Objective: To evaluate the effect of moisturizing emollients containing ophiopogon japonicus root extract treatment on adult atopic dermatitis.Methods: It was a randomized,double-blind and well-parallel control trial involved the participation of the department of dermatology from September 2015 to April 2016.110 cases of above 16 years old with a slight to moderate AD adults were pre-included.At the pre-inclusion visit(V1),all patients previously requiring a prescription for a topical corticosteroid and oral antihistamines for a maximum treatment of(2-4)weeks until remission phase.Remisson phase was defined as the sum of scores of erythema,edema/papules,exudation/crust,excoriation and pruritus was equal to 0.And confirmed inclusion will be valid only if patients in remission phase.Patients who were included were randomly divided into experiment group and control group by means of random number table.The experiment group was treated with DIPFAL001 cream,and the control group was treated with DI0WY001 cream,all for external use on the whole body twice a day.It was double-blinded designed for researchers and patients,the emollients were supplied by sponsor in identical packaging labeled,and there was a specific distributor assigned emollients to patients.O nce the patient appears erythema,edema/papules,exudation/crust,excoriation and pruritus,any signs or symptoms,it would be treated as “relapse”.Visits would be carried out after 0 day,30 days and 60 days of emollients application for second visit(V2/D0),third visit(V3/D30)and fourth visit(V4/D60),respectively.The outcomes included the relapse rate of atopic dermatitis adults,clinical examination for SCORAD assessment by the dermatologist,dermatology life quality index(DLQI)measurement by the patients,and evaluation on emollients were performed both by dermatologists and patients at V3/D30 and V4/D60 respectively.Results: 110 mild to moderate AD adults were pre-inclusion into the study,34 cases were loss of follow-up after a maximum prescription treatment for 2-4 weeks,76 cases were final included,38 cases were in both experiment group and control group,respectively.And during the whole follow-up period,16 cases were relapsed,4 cases in experiment group and 12 cases in control group.13 cases were relapsed between 0 and 30 days,2 cases in experiment group and 11 cases in control group.and the other 3 cases were relapsed between 30 and 60 days,2 cases in experiment group and 1 cases in control group.The average relapse time was 23 days(<30 days).The time for using emollients were too short to analysis.and 60 cases which were total complete the study were involved into statistics ultimately,aged 18-55 years old,25 males and 35 females.34 cases in experiment group and 26 cases were in control group.Study variables: 1.Relapse rate: on the whole study,12 cases were relapsed in control group and 4 cases in experiment group,respectively.it showed that the relapse rate in the experiment group is significantly less than that in the control group(P<0.05).2.SCORAD values: At V2/D0,V3/D30 and V4/D60,the SCORAD values were respectively(control group:10.00±5.24,6.91±5.79,4.43±4.43;experiment group: 12.31 ±4.73,7.94±4.93,2.96±3.69).At baseline(V2/D0),there was no significant difference in SCORAD values between two groups(P>0.05);at V3/D30 and V4/D60,SCORAD values for both of the two groups were reduced significantly compared to baselines(P<0.05).And compared to baseline,at V3/D30 and V4/D60 reductions in SCORAD values were respectively(control group: 3.09±2.98,5.56±3.61;experiment group: 4.37±2.93,9.35±3.90),there was no obvious difference in SCORAD reductions between two groups at V3/D30(P>0.05),but a significant SCORAD reduction with the experiment group was observed by the dermatologist versus control group at V4/D60(P<0.05).3.DLQI values: At V2/D0,V3/D30 and V4/D60,DLQI values in two groups were respectively(control group:6.19±4.45,4.65±3.85,3.31±3.37;experiment group: 7.71±5.08,5.06±3.90,2.44±2.82).At baselines(V2/D0),there was no significant differences in DLQI values between two groups(P>0.05);at V3/D30 and V4/D60,the DLQI values had a significant reduction for both groups compared to baselines(D0)(P<0.05).And compared to baselines,at V3/D30 and V4/D60 reductions in DLQI values were respectively(control group:1.54±1.92,2.88±2.96;experiment group:2.65±3.79,5.26±4.60).there was no obvious difference in DLQI reductions between two groups at V3/D30(P>0.05).However,a significant DLQI reduction with the experiment group was observed by the patients versus control group at V4/D60(P<0.05).4.Dermatologists assessments: at V3/D30,there was no statistical difference between the two groups in hydrating effect,softening effect,flares intensity reduction,flares frequency reduction,well tolerated production and satisfactory overall(P>0.05);at V4/D60,compared to control group,the treatment of experiment group had more advantages in hydrating effect(P<0.05);and evaluation on the other items showed no obvious d ifference between two groups,but it demonstrated a higher favorable rate in experiment group compared with control group(P>0.05).5.Patients assessment: No significant differences between two groups in all items at V3/D30(P>0.05).but at V4/D60,the favorable rate of hydrating effect in experiment group was higher than that in control group(P<0.05),and no significant results for other items between two groups at V4/D60(P>0.05).6.No safety affairs were observed during the whole study.Conclusion: The moisturizing and anti-inflammatory emollients containing ophiopogon japonconicas root extract indicates a good curative and safety efficacies on adult atopic dermatitis;it could alleviate the disease,reduce the recurrence and improve the quality of life of patients.it is useful for treatment adjuncts in atopic dermatitis. |
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