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


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.


CONCLUSIONS
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.
Borelli
C
C
Klinik und Poliklinik für Dermatologie und Allergologie der Ludwig-Maximilians-Universität, München, Deutschland. claudia.borelli@med.uni-muenchen.de
Gassmueller
J
J
Fluhr
J W
JW
Nietsch
K H
KH
Schinzel
S
S
Korting
H C
HC
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000378:metabolism / Q000494:pharmacology*; D001623:Betamethasone / Q000008:administration & dosage / Q000378:metabolism / Q000494:pharmacology*; D001682:Biological Availability; D002990:Clobetasol / Q000008:administration & dosage / Q000378:metabolism / Q000494:pharmacology*; D003899:Desoximetasone / Q000008:administration & dosage / Q000378:metabolism / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000378:metabolism / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles; D012867:Skin / Q000098:blood supply*; D012869:Skin Absorption; D014661:Vasoconstriction / Q000187:drug effects*; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000378:metabolism / Q000494:pharmacology*
D000893:Anti-Inflammatory Agents; D014677:Pharmaceutical Vehicles; D014662:Vasoconstrictor Agents; D003899:Desoximetasone; D001623:Betamethasone; D002990:Clobetasol; D006854:Hydrocortisone