Topical Tacrolimus versus Hydrocortisone on Atopic Dermatitis in Paediatric Patients: A Randomized Controlled Trial

Abstract

Atopic dermatitis (AD) is a chronic, inflammatory skin disease in early childhood. Atopic dermatitis is familial disease, often coexists with other atopic diseases with multiple risk factors associated with atopic eczema. The disease is more frequent in urban areas compared with rural areas. Changes in nutrition and a decrease in infant breast-feeding and respiratory allergies are contributory factors for the condition. A Randomized Controlled Trial (RCT) was carried to compare the efficacy and safety of Tacrolimus ointment with a topical corticosteroid reference therapy. A total 60 patients aged between 2 to 10 years, having atopic dermatitis for at least one year and comply Hanifin-Rajka criteria were selected using random number table and allocated into study and control groups through randomization. Study group was treated with topical Tacrolimus 0.03% twice daily for three weeks, while the control group was treated with 1% Hydrocortisone acetate for the same period. Both groups had a washed out phase for 2 weeks with a follow up period of 6 weeks. Eczema Area and Severity lndex (EASI) was assessed at baseline and three weeks after treatment. Efficacy was evaluated at each visit by six clinical signs of atopic dermatitis through measurement of the affected surface area and the EASI score in each of four body regions. Before intervention, in study group mean EASI score was 11.29 with a SD of 2.14, while in control group it was 11.05 with a SD of 2.46. Difference was statistically insignificant (p>0.05). At the end of the treatment, in study group mean EASI score was 4.86 with a SD of 1.01, while in control group it was 7.97 with a SD of 1.80. Statistically high significant difference was observed between EASI scores of two groups before and after the treatment (p<0.001). After getting treatment with Tacrolimus, median reduction of EASI score was 56.07 in study group, while getting treatment with Hydrocortisone, median reduction of EASI score was 27.16. Difference was highly significant (p<0.001). It is evidenced that Tacrolimus ointment (0.03%) acts as an effective as well as safe non-steroidal topical therapy for the treatment of dermatitis in paediatric patients.