ABSTRACT
Objective To evaluate the safety and efficacy of recombinant bovine basic fibroblast growth factor in the treatment of corticosteroid-dependent dermatitis.Methods A randomized,double-blind,placebo-controlled clinical trial was carried out.By simple randomization,64 patients with corticosteroid-dependent dermatitis were randomly and equally divided into 2 groups:treatment group topically applying recombinant bovine basic fibroblast growth factor gel twice a day for 4 consecutive weeks,and control group topically applying the gel vehicle twice a day for 4 consecutive weeks.Clinical symptoms and signs were scored before the treatment and after 1-,2-and 4-week treatment.Meanwhile,the water content of the stratum corneum,skin sebum content and transepidermal water loss (TEWL) of the skin lesions were detected.Results Thirty-one patients in the treatment group and 30 in the control group completed the trial.The clinical symptom and sign scores in the treatment group were significantly lower at week 2 and 4 after starting treatment (1.35 ± 0.55 and 1.00 ± 0.45,respectively) than that before treatment (2.77 ± 0.43,both P ＜ 0.05),as well as lower at week 1 (2.06 ± 0.51),2 and 4 after starting treatment than that in the control group (2.43 ± 0.57,2.17 ± 0.53,1.93 ± 0.45,respectively,all P ＜ 0.05).The treatment group showed significantly increased water content of the stratum corneum at week 4 after starting treatment,significantly increased skin sebum content,but decreased TEWL at week 2 and 4 after starting treatment compared with those before treatment (all P ＜ 0.05).Compared with the control group,the treatment group showed significantly higher skin sebum content at week 2 and 4 after starting treatment,higher water content of the stratum corneum,but lower TEWL at week 4 after starting treatment (all P ＜ 0.05).No adverse reactions were observed in either of the 2 groups.Conclusion Recombinant bovine basic fibroblast growth factor is effective and safe for the treatment of corticosteroid-dependent dermatitis,and contributes to repairing and reconstructing the skin barrier function.
ABSTRACT
Objective To estimate the efficacy and safety of 5-aminolevulinic acid-based photodynamic therapy (ALA-PDT) in the treatment of lichen sclerosus et atrophicus of the vulva.Methods An open and noncontrolled clinical study was performed.Forty-two patients were enrolled in this study and received ALA-PDT once every two weeks for 2 to 4 times.Follow-up visits were arranged at 2,4 and 8 weeks after initiation of treatment,and patients were evaluated at the baseline (before treatment) and all the follow-up time points for the efficacy and safety of treatment.Results Finally,38 patients completed the trial and 4 patients were lost to follow up.The total response rate was 81.6％ (31/38) at the end of the treatment.The average symptom and sign score in these patients was significantly lower at 2,4 and 8 weeks after initiation of treatment than that before treatment (17.6 ± 10.18,11.6 ± 8.35 and 7.6 ± 5.93 vs.29.3 ± 9.17,t =5.26,8.80,12.22,respectively,all P ＜ 0.01).A significant improvement was also observed in the other aspects,such as skin lesion area,hypopigmentation,erosion/rhagades and itching score at 2,4 and 8 weeks,as well as in skin atrophy at 8 weeks after initiation of treatment compared with those before treatment (all P ＜ 0.05).Local burning sensation was the main adverse reaction to ALA-PDT,and 16％ (6/38) of these patients complained of severe pain during the first treatment.Conclusion ALA-PDT shows favorable efficacy in patients with lichen sclerosus et atrophicus of the vulva with a rapid onset of action.