The safety of calcitriol 3 microg/g ointment. Evaluation of cutaneous contact sensitization, cumulative irritancy, photoallergic contact sensitization and phototoxicity

Eur J Dermatol. 2001 May-Jun;11(3):219-24.

Abstract

Vitamin D analogues are widely used for the treatment of psoriasis. A new topical formulation of calcitriol (3 microg/g ointment) has been shown to be effective in the treatment of stable plaque-type psoriasis. This paper reports the results of four separate studies designed to evaluate specific local-safety parameters: cumulative irritancy, cutaneous contact sensitization, potential photoallergic contact sensitization and phototoxicity. Calcitriol 3 microg/g ointment was classified as non-irritant when compared to calcipotriol, tacalcitol and white petrolatum. Petrolatum and tacalcitol were slightly irritant and calcipotriol moderately irritant. No sensitization was observed with calcitriol 3 microg/g ointment. With regard to phototoxic potential, sites treated with calcitriol 3 microg/g ointment or vehicle ointment were less irritated than those treated with white petrolatum or those that were untreated. Using standard photoallergenicity testing methodology, there were no skin reactions of a photoallergic nature to the study material. These studies showed that calcitriol 3 microg/g ointment is a well-tolerated treatment for stable plaque-type psoriasis.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Anti-Inflammatory Agents / adverse effects*
  • Calcitriol / adverse effects*
  • Calcitriol / analogs & derivatives
  • Dermatitis, Allergic Contact / etiology*
  • Dermatitis, Allergic Contact / pathology
  • Dermatitis, Photoallergic / etiology*
  • Dermatitis, Photoallergic / pathology
  • Dermatitis, Phototoxic / etiology*
  • Dermatitis, Phototoxic / pathology
  • Dermatologic Agents / adverse effects*
  • Dihydroxycholecalciferols / adverse effects*
  • Emollients / adverse effects*
  • Humans
  • Ointments
  • Petrolatum / adverse effects*
  • Psoriasis / drug therapy*
  • Safety
  • Severity of Illness Index
  • Single-Blind Method
  • Time Factors

Substances

  • Anti-Inflammatory Agents
  • Dermatologic Agents
  • Dihydroxycholecalciferols
  • Emollients
  • Ointments
  • calcipotriene
  • 1 alpha,24-dihydroxyvitamin D3
  • Petrolatum
  • Calcitriol