Studies were conducted to assess the bioequivalence of a new antimycotic formulation,
ciclopirox olamine lotion 1%, to an established compound,
ciclopirox olamine cream 1%. Results of in vitro studies, using skin samples from human cadavers and domestic pigs, demonstrated that the two formulations equally penetrate all layers of the stratum corneum and inhibit the growth of Trichophyton mentagrophytes and Candida albicans. In vivo studies in guinea pigs and in human volunteers demonstrated the comparable therapeutic efficacy of the lotion and the cream in experimental
trichophytosis. In addition, a multicenter, double-blind clinical trial was undertaken to compare
ciclopirox olamine lotion 1% with the vehicle alone in the treatment of patients with
tinea pedis. Patients with plantar, interdigital, or vesicular
tinea pedis were enrolled in the studies. Patients were treated for 28 days. Clinical and mycological responses were determined during treatment and two weeks posttreatment.
Ciclopirox olamine lotion 1% was found to be significantly more effective than its vehicle in the treatment of patients with common
tinea pedis. Minor localized side effects (
pruritus, burning sensation) were reported in 2% of 89 patients treated with
ciclopirox olamine lotion 1%. The results demonstrate the bioequivalence of
ciclopirox olamine lotion 1% and
ciclopirox olamine cream 1% and confirm the clinical effectiveness and safety of the lotion in the treatment of
tinea pedis, a generally recalcitrant
fungal infection. It is concluded that
ciclopirox olamine lotion 1% can be used as an alternative to
ciclopirox olamine cream 1% for treatment of
tinea pedis,
tinea versicolor,
tinea cruris,
tinea corporis, and
cutaneous candidiasis when the convenience and/or cosmetic elegance of a lotion is desired.