[Multicentre-clinical trial of the novel corticosteroid diflucortolone valerate in the forms of cream, ointment and fatty ointment. Part I: Comparative study of diflucortolone valerate with fluocortolone, -capronate, -pivalate in a double-blind contralateral design with topical application (author's transl)].
6alpha,9-Difluor-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, Nerisona) 0.1% as a cream, ointment and fatty ointment was investigated in a double-blind contralateral design in 925 patients in comparison to fluocortolone (Ultralan), fluocortolone caproate and fluocortolone pivalate in three concurrently performed studies. The results of the contralateral study show Nerisona cream and ointment to be more effective (P less than 0.01) than Ultralan. The fatty ointment was also superior, but the difference was statistically significant (P less than 0.05) only in the indication psoriasis. No differences could be established in the less sensitive absolute assessment. The therapeutic success rate of 76-92% according to strict criteria-only complete healing and distinct improvement were counted as a success-clearly demonstrates the efficacy of the preparations. The local side effects recorded-mainly irritation and burning- were of a mild nature.
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003872:Dermatitis / Q000188:drug therapy; D004655:Emulsions; D005448:Fluocortolone / Q000031:analogs & derivatives / Q000627:therapeutic use; D005938:Glucocorticoids; D006801:Humans; D008010:Lichen Planus / Q000188:drug therapy; D009823:Ointment Bases; D011244:Pregnadienediols / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy; D012871:Skin Diseases / Q000188:drug therapy*; D013259:Steroids, Fluorinated / Q000627:therapeutic use
D000893:Anti-Inflammatory Agents; D004655:Emulsions; D005938:Glucocorticoids; D009823:Ointment Bases; D011244:Pregnadienediols; D013259:Steroids, Fluorinated; D005448:Fluocortolone
Multizentrische klinische Prüfung des neuen Corticosteroids Diflucortolon-valerianat als Creme, Salbe und Fettsalbe. I: Vergleichende Untersuchungen von Diflucortolonvalerianat und Fluocortolon, -capronat, -pivalat bei lokaler Applikation im doppelblinden Halbseitenversuch