Side-by-Side Comparative Study of a Moisturizer and Topical Tacrolimus for Treating Mild to Moderate Atopic Dermatitis: A Randomized Single-Blinded Clinical Trial

Abstract

The appropriate use of therapeutic moisturizers could reduce the need for more aggressive treatment in the management of atopic dermatitis (AD). We conducted a randomized, side-by-side, single-blinded, comparative study in 41 mild to moderate AD patients to compare a moisturizer and topical tacrolimus for restoring skin barrier function and managing AD. A moisturizer was applied twice daily for 4 weeks to one side of the flexural areas (moisturizer group). Topical tacrolimus was applied on the other side of the tested area (tacrolimus group). Biophysical skin parameters were measured at baseline, week 2, and week 4. Clinical qualitative assessments were also conducted. Analysis of the trend from baseline to week 4 revealed that the hydration level was significantly increased in both groups ( $p<0.01$ , respectively). No biophysical parameters were significantly different between the two groups. Differences in the modified Eczema Area and Severity Index scores between the baseline and week 4 were significantly higher in the tacrolimus group than those in the moisturizer group ( $p=0.002$ ). In the Investigator’s Global Assessment, a significantly larger proportion of patients in the tacrolimus group showed clinical improvement than that in the moisturizer group at week 4 ( $p=0.027$ ). Although topical tacrolimus was superior to the moisturizer in preventing the clinical exacerbation of AD, the moisturizer was not inferior to topical tacrolimus in restoring skin barrier function. Therefore, moisturizer is considered to play an essential role in maintenance therapy for AD. Physicians need to emphasize the benefits of moisturizers when educating their patients.