A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay

Arch Dermatol. 1991 Feb;127(2):197-201.

Abstract

Six generic formulations of five topical steroids were compared for bioequivalence with their trade-name counterparts using an in vivo vasoconstriction assay. Two of six generic formulations were found to show significantly less vasoconstriction than the respective trade-name topical steroids. The issue of generic equivalence of topical steroids is discussed, with particular emphasis on the vagaries of the vasoconstriction assay.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Administration, Topical
  • Adult
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / pharmacokinetics*
  • Betamethasone / administration & dosage
  • Betamethasone / analogs & derivatives*
  • Betamethasone / pharmacokinetics*
  • Double-Blind Method
  • Fluocinolone Acetonide / administration & dosage
  • Fluocinolone Acetonide / pharmacokinetics*
  • Glucocorticoids
  • Humans
  • Middle Aged
  • Therapeutic Equivalency
  • Vasoconstriction

Substances

  • Anti-Inflammatory Agents
  • Glucocorticoids
  • Fluocinolone Acetonide
  • betamethasone-17,21-dipropionate
  • Betamethasone