Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay
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vor 16 Jahren
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
non-inferior 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. Copyright (C) 2008 S. Karger AG, Basel.
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
non-inferior 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. Copyright (C) 2008 S. Karger AG, Basel.
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