Pimecrolimus cream 1% vs. betamethasone 17-valerate 0.1% cream in the treatment of seborrhoeic dermatitis. A randomized open-label clinical trial

BACKGROUND: Seborrhoeic dermatitis is a chronic inflammatory disease with remissions and exacerbations, characterized by erythema, scaling and pruritus primarily on the face, scalp and chest. Corticosteroids and antifungals are the mainstay of therapy. However, chronic use of corticosteroids is associated with side-effects such as skin atrophy and telangiectasia. Pimecrolimus, an inhibitor of calcineurin, has been used successfully in one patient with seborrhoeic dermatitis. OBJECTIVES: The objective of this randomized open-label clinical trial was to compare the efficacy and tolerability of pimecrolimus in comparison with a potent corticosteroid (betamethasone 17-valerate) in the treatment of seborrhoeic dermatitis. METHODS: Twenty patients with seborrhoeic dermatitis were included in this study, 11 patients in the pimecrolimus 1% cream group and nine patients in the betamethasone 17-valerate 0.1% cream group. Patients were instructed to use a thin layer of the study products twice daily at the lesional area and to discontinue treatment as soon as symptoms were absent. Clinical measures assessed were erythema, scaling and pruritus which were evaluated using a four-point scale (0-3). RESULTS: Both pimecrolimus and betamethasone were highly effective in the treatment of seborrhoeic dermatitis. Betamethasone reduced all three parameters, erythema, scaling and pruritus, faster than pimecrolimus, but the differences in reduction were not statistically significant. Relapses were observed more frequently and were more severe with betamethasone than with pimecrolimus. Moreover, pruritus was not observed after discontinuation of treatment from day 15 and beyond in the pimecrolimus group, whereas it was reported in most patients of the betamethasone group. This difference was statistically significant. CONCLUSIONS: It appears that pimecrolimus, a nonsteroidal topical treatment, may be an excellent alternative therapeutic modality for treating seborrhoeic dermatitis.