Efficacy and safety of 0.1% Tacrolimus ointment versus 0.05% Clobetasone butyrate ointment in childhood atopic dermatitis

Abstract

Introduction: Atopic dermatitis (AD) is a chronic relapsing skin condition characterized by intense itching, dry skin, redness, in_ammation and exudation with signi_cant morbidity. It often requires long-term use of topical corticosteroids but, patients’ adherence to corticosteroids may be limited by perceived risks and systemic adverse e_ects. Therefore, steroid-sparing topical agent is needed. To compare the e_cacy and safety of 0.1% tacrolimus ointment and 0.05% clobetasone butyrate ointment in patients with childhood AD. 

Materials and methods: This monocentric prospective open-label comparative study was carried out in the Department of Dermatology and Venereology, Chittagong Medical College Hospital. Two hundred patients of 2–10 years of age with mild to moderate AD involving _ 50% of the total body surface area (BSA) were randomly assigned. The treatment duration was 4 weeks and was followed-up for 12 weeks. The eczema area and severity index (EASI) and the physician’s global evaluation of clinical response were assessed and evaluated. 

Results: E_ective sample size was 176 as because 24 patients were dropped out during follow up. EASI score was signi_cantly changed from baseline in follow up weeks and there was a statistically signi_cant di_erence in the reduction of EASI of patients in Tacrolimus groups at the end of 2nd week, 4th week, 6th week than the other group (p < 0.05). At the end of 4 weeks treatment, a median improvement of _ 75% in EASI was observed in 86% and 57% of patients in Tacrolimus and Clobetasone Group, respectively. At the end of the 12 week follow-up period, these improvements persist. Both the regimens were well tolerated.

Conclusions: The overall therapeutic e_ectiveness was in favour of topical Tacrolimus ointment (0.1%) over topical Clobetasone butyrate ointment (0.05%) for the treatment of AD in children.