Background

Facial seborrheic dermatitis (FSD) as a chronic inflammatory skin disorder is characterized by remission and exacerbation episodes. In most cases, FSD requires a long-term treatment.

Objectives

This study aimed to compare the efficacy and safety of pimecrolimus and sertaconazole in patients with FSD.

Methods

In this double-blinded, and randomized trial 60 patients with FSD were included and instructed to topically apply either pimecrolimus 1% cream (30 patients) or sertaconazole 2% cream (30 patients) twice daily for 4-weeks. Assessment of the disease severity was performed at baseline, on day 14 and day 28, and 4 weeks after termination of treatment, based on Scoring Index (SI). The levels of satisfaction from treatment and side effects were also assessed in both groups.

Results

Although the severity of disease reduced upon treatment in both groups, application of pimecrolimus caused a significant improvement as compared to the sertaconazole on day 14 and day 28 (P=0.002 and P<0.001, respectively). The rate of relapse was significantly lower in the pimecrolimus group as compared to the sertaconazole after 28 days of treatment termination (P=0.012). The highest level of satisfaction (46.7%) was observed on day 28 in pimecrolimus group. Both of topical treatments had acceptable safety profiles, however, pimecrolimus 1% cream showed more safety compared to the sertaconazole 2% cream, in the term of irritation (P=0.003).

Conclusion

This study showed that pimecrolimus was associated with a quicker response and fewer side effects as compared to sertaconazole in patients with FSD.