e-Prints Soton - Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitisReitamo, Sakari, Rustin, Malcolm, Ruzicka, Thomas, Cambazard, Fr d ric, Kalimo, Kirsti, Friedmann, Peter S., Schoepf, Erwin, Lahfa, Mourad, Diepgen, Thomas L., Judodihardjo, Harryono, Wollenberg, Andreas, Berth-Jones, John and Bieber, ThomasResults: Five hundred seventy patients were randomized and received treatment. Discontinuations included 22 of 193 patients from the 0.03% tacrolimus group, 22 of 191 patients from the 0.1% tacrolimus group, and 17 of 186 patients from the hydrocortisone butyrate group. The median mEASI mean area under the curve as a percentage of baseline was 47.0%, 36.5%, and 36.1% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 0.1% hydrocortisone butyrate, respectively. There was no statistically significant difference between 0.1% tacrolimus and 0.1% hydrocortisone butyrate; however, the lower improvement in mEASI for 0.03% tacrolimus was statistically significant when compared with 0.1% tacrolimus (P .001) or hydrocortisone butyrate (P = .002). Skin burning and pruritus at the application site showed a higher incidence in the tacrolimus treatment groups than in the hydrocortisone butyrate group (P .05). Laboratory parameters showed no treatment differences and no marked changes over time.
