Evaluation of the in vitro and in vivo efficacy of butenafine hydrochloride cream 1% against Malassezia furfur species and seborrheic dermatitis

Abstract

BACKGROUND/AIMS: Seborrheic dermatitis is a relatively common condition which may be seen on the face and central chest. Malassezia furfur has been implicated in the aetiology of this condition. Butenafine cream 1% is a benzylamine that is fungicidal in vitro, against dermatophytes and other organisms. This study aims to determine the in vitro antifungal activity of butenafine relative to other antifungal agents against M. furfur , to investigate the in vivo elimination of M. furfur normally present in microcomedones following topical application of butenafine cream 1%, and the efficacy of butenafine cream 1% against seborrheic dermatitis of the face. METHODS: Tween 80-containing medium was used to determine the antifungal activity of butenafine relative to naftifine, tolnaftate, and clotrimazole against six strains of M. furfur . The effect of topical butenafine HCl cream 1% applied twice daily for 2 weeks to treat M. furfur from microcomedones was evaluated in 10 healthy adult Caucasian women with oily skin and post-adolescent acne. The density of M. furfur within microcomedones of the forehead was measured at baseline, one and two weeks following twice daily application of butenafine HCl cream 1%. To determine the efficacy of butenafine HCl cream 1% in facial seborrheic dermatitis ten subjects with classical signs of facial seborrheic dermatitis were enrolled in an open, single-center study. Butenafine HCl cream 1% was applied to the entire face twice daily for three weeks. RESULTS: Butenafine exhibited almost the same activity as clotrimazole against M. furfur , whereas, naftifine was about eight times weaker in activity compared to butenafine. Tolnaftate did not demonstrate activity against M. furfur up to 100 µ g/ml. By one week of butenafine HCl cream 1% treatment there was already nearly complete suppression of M. furfur growth in vivo compared to baseline. M. furfur was essentially absent in every subject by two weeks. Butenafine HCl cream 1% treatment was effective in eliminating M. furfur from microcomedones and was well tolerated. With regards to the efficacy of butenafine HCl cream 1% in facial seborrheic dermatitis by week three, six of ten subjects had cleared and the remaining four exhibited moderate improvement. CONCLUSION: Butenafine exhibits in vitro and in vivo activity against Malassezia species, being markedly more effective than naftifine and with about the same activity as clotrimazole in vitro. In a pilot study butenafine demonstrated effectiveness in the topical treatment of seborrheic dermatitis. The results need to be confirmed in a larger trial. (J Dermatol Treat (2000) 11:79-83)