Topical 0.03% tacrolimus ointment, 0.05% clobetasone butyrate cream alone and their combination in older children with atopic dermatitis - an open randomized comparative study

Background Atopic dermatitis, a chronic recurring inflammatory skin disease, often requires long-term use of topical corticosteroids that may cause serious adverse effects. Therefore, steroid sparing topical agent is needed. Objective In this open, randomized and comparative study, the efficacy and safety of 0.03% tacrolimus ointment, 0.05% clobetasone butyrate cream and their combination were evaluated in patients with AD. Patients and methods 45 patients with moderate to severe AD involving with moderate to severe AD involving .50% of the total body surface area (BSA) were randomly assigned to three groups. 15 patients in each group received 0.03% tacrolimus ointment twice daily (arm A) or 0.05% clobetasone butyrate cream twice daily (arm B) or 0.05% clobetasone butyrate cream in the morning and 0.03% tacrolimus ointment in evening (arm C). The treatment duration was 4 weeks and was followed-up for 6 weeks. The modified eczema area and severity index (mEASI) and the extent of the affected BSA were assessed and evaluated. Results All treatment groups showed significant improvement throughout the treatment period. At the end of 4 weeks treatment, a median improvement of .75% in mEASI was observed in 53.3%, 73.3% and 93.3% of patients in arms A, B and C, respectively (endpoint analysis 1) and at the end of follow-up this improvement remained at the rate of 87.5%, 63.6% and 85.7% respectively (endpoint analysis 2). Only 13.3% patients who received 0.03% tacrolimus ointment experienced excellent improvement and clearance by the end of the treatment compared with 66.7% patients who received 0.05% clobetasone butyrate and 93.3% patients who received combination regimens. Skin burning was common in the 0.03% tacrolimus treatment group than in the 0.05% clobetasone butyrate group (7/15 vs. 1/15, p=0.010) and in the combination regimen group (7/15 vs.2/15, P=0.042). Conclusion The overall therapeutic effectiveness and safety were in favor of combination regimens.