Effectiveness of Proactive Therapy in Pediatric Atopic Dermatitis Patients with 0.03% Tacrolimus Ointment versus 0.02% Triamcinolone Acetonide Cream: A Prospective Randomized Split-Side Single-Blinded Controlled Trial

Abstract

Background: Along with reactive treatment aiming to control disease flares, atopic dermatitis (AD) patients can use proactive treatment to halt subclinical inflammation of normal-appearing skin and prevent exacerbation.

Objectives: To determine and compare the effectiveness and adverse effects of 0.03% tacrolimus ointment and 0.02% triamcinolone acetonide (TA) cream twice weekly as proactive therapy.

Materials and Methods: This 4-month prospective single-blinded randomized controlled trial included thirty-eight patients, aged 2-14 years old, with moderate AD (SCORAD 25-50). In the first two months, the patients applied a cream base twice daily and 0.02% TA cream as reactive therapy. In the next two months, 0.03% tacrolimus ointment and 0.02% TA cream were additionally given as proactive therapy to be applied twice weekly at selected normal-appearing areas on each side, randomly assigned between left and right sides of the antecubital or popliteal fossae. The patients were evaluated every four weeks. Outcome measures included number of disease exacerbations, disease-free days, duration to first exacerbation, and adverse effects.

Results: Thirty-eight patients completed the study. In contrast to 0.02% TA, twice weekly 0.03% tacrolimus ointment helped to reduce the number of disease exacerbations with a p-value of 0.029 and increased the total number of disease-free days by 1.5 days (p = 0.02). Both agents as proactive treatment significantly delayed the next disease flare. No adverse reaction was reported during the study.

Conclusion: We suggest using proactive therapy with 0.03% tacrolimus ointment in moderate AD patients, while 0.02% TA cream may be considered in cases of limited budget.