Pimecrolimus cream (1%) efficacy in perioral dermatitis – results of a randomized, double‐blind, vehicle‐controlled study in 40 patients

Abstract

Results suggest that pimecrolimus cream (1%) effectively treats acute-stage POD.

Efficacy and Safety Results of a Drug-Free Cosmetic Fluid for Perioral Dermatitis: The Toleriane Fluide Efficacy in Perioral Dermatitis (TOLPOD) Study

“…As there are no clinical trial data comparing pimecrolimus cream (1%) with a soothing fluid, we decided to compare published historical data of both treatment regimens. The improvement seen after 4 weeks of pimecrolimus cream (1%) treatment is slightly better than with the soothing fluid8, which may be attributed to the anti-inflammatory properties of the calcineurin inhibitor, pimecrolimus.…”

“…Fortunately, there are historical data published from clinical trials with pimecrolimus cream (1%) that also used the PODSI as the outcome measure and included a control group8. The placebo group of that study consisted of 20 patients, 18 of whom completed the 4-week treatment period.…”

“…The composition of the vehicle cream in this pimecrolimus cream (1%) trial was identical to that of the commercial pimecrolimus cream (1%), with the exception of the missing active ingredient, pimecrolimus8.…”

“…To approximately compare the efficacy of the soothing fluid with the published data, we visualized the TOLPOD data together with historical, published data from a vehicle-controlled study with pimecrolimus cream (1%; Elidel; Novartis, Nuremberg, Germany) and a pimecrolimus-free cream base that also used the PODSI as the outcome measure8. The composition of the vehicle cream in this pimecrolimus cream (1%) trial was identical to that of the commercial pimecrolimus cream (1%), with the exception of the missing active ingredient, pimecrolimus8.…”

“…R 2 =0.08389. (C) Time course of PODSI in 39 patients with POD treated for 8 weeks with a soothing fluid, as well as a historical control of 20 patients treated for 4 weeks with a cream base and untreated for another 4 weeks8. There was better improvement with the soothing fluid; however, the differences observed were not significant.…”