Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.

INTRODUCTION: We report on a double-blind, vehicle-controlled, single-center confirmatory study with random assignment. The purpose of the study was to investigate the topical bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone (DM). MATERIALS AND METHODS: Two DM 0.25% formulations [ointment (DM-o) and fatty ointment (DM-fo, water-free); class III corticosteroids], the corresponding active ingredient-free vehicles and three comparators of different strength [clobetasol propionate 0.05% (CP 0.05%), fatty ointment, class IV; hydrocortisone (HC) 1%, fatty ointment, class I, and betamethasone (BM) 0.05%, fatty ointment, class III] were tested using the vasoconstriction assay. The degree of vasoconstriction (blanching) in the treatment field was compared to the one found in untreated control fields using chromametric measurements and clinical assessment. RESULTS/CONCLUSION: DM-o 0.25%, DM-fo 0.25% and BM 0.05% showed similar vasoconstrictive potential, i.e., clear blanching. In fact, both DM preparations were proven to be noninferior to BM 0.05%, while CP 0.05% was found a little less active. HC 1.0% and the DM vehicles showed no clear-cut vasoconstrictive effect. No adverse events related to the study medications were observed. Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment.

Ciclopiroxolamine cream for treating seborrheic dermatitis: a double-blind parallel group comparison.

BACKGROUND: The aim of this study was to compare the efficacy and tolerability of topically applied ciclopiroxolamine cream with that of the corresponding vehicle in patients with seborrheic dermatitis of the face. PATIENTS AND METHODS: The study was conducted as a multicenter prospective, randomized, double-blind parallel group comparison at 14 centers in Australia and New Zealand. 189 patients with clinically diagnosed seborrheic dermatitis participated in the study. Each patient applied ciclopiroxolamine 1% cream or the corresponding vehicle twice daily as a thin film to the affected skin areas and to clinically unaffected skin areas surrounding the lesions for 29 days. RESULTS: The rate of treatment success was significantly higher with ciclopiroxolamine than with vehicle (73.9 vs 53.6%; p = 0.003). Treatment with ciclopiroxolamine reduced the sum score of the clinical signs of seborrheic dermatitis to a greater extent than the vehicle (p

A multicenter, open-label study of the efficacy and safety of ciclopirox nail lacquer solution 8% for the treatment of onychomycosis in patients with diabetes.

This multicenter, open-label, uncontrolled, noncomparative, observational, postmarketing study assessed the efficacy and safety of ciclopirox nail lacquer solution 8% in 3666 patients for the treatment of onychomycosis. Results of an analysis in a subset of 215 (5.9%) patients with diabetes are summarized here. Patients applied ciclopirox nail lacquer once daily to affected toenails and fingernails for 6 months. Efficacy parameters included the decrease from baseline of the affected area of the nail. Physicians rated the level of onychomycosis at 3 months and the efficacy of ciclopirox nail lacquer at 6 months. Treatment with ciclopirox nail lacquer reduced the mean affected nail area from 64.3% at baseline to 41.2% at 3 months and 25.7% at 6 months. At 3 months, physicians rated onychomycosis as improved in 88.7% of patients. unchanged in 9.8%, and worse in 1.5%. The efficacy of ciclopirox nail lacquer was good in 62.0% of patients, satisfactory in 23.9%, and unsatisfactory in 14.1%. Adverse events were mild to moderate, with no serious events reported. Ciclopirox nail lacquer is safe and effective for the topical treatment of onychomycosis in patients with diabetes and produced results similar to those observed in the general population.