The efficacy and safety of pimecrolimus 1% cream vs. sertaconazole 2% cream in the treatment of patients with facial seborrhoeic dermatitis: a randomized blinded trial.

BACKGROUND

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

AIM

To compare the efficacy and safety of pimecrolimus and sertaconazole in patients with FSD.

METHODS

In total, 60 patients with FSD were enrolled in this double-blind, active-controlled, randomized trial, and instructed to topically apply either pimecrolimus 1% cream (30 patients) or sertaconazole 2% cream (30 patients) twice daily for 4 weeks. Assessment of disease severity was performed using the Scoring Index (SI) at baseline, on Days 14 and 28, and at 4 weeks after treatment cessation. The levels of satisfaction from treatment and any adverse effects (AEs) were also assessed in both groups.

RESULTS

Although the severity of disease reduced upon treatment in both groups, application of pimecrolimus caused a significantly better improvement than sertaconazole on Days 14 and 28 (P < 0.01 and P < 0.001, respectively). The rate of relapse was significantly lower in the pimecrolimus compared with the sertaconazole group at 4 weeks after treatment cessation (P = 0.01). The highest level of satisfaction (46.7%) was observed on Day 28 in the pimecrolimus group. Both topical treatments had acceptable safety profiles; however, pimecrolimus 1% cream was significantly (P < 0.01) less irritating than sertaconazole 2% cream.

CONCLUSION

Pimecrolimus is associated with faster response and fewer AEs than sertaconazole in patients with FSD.