A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis

Dermatology. 2008;217(4):321-8. doi: 10.1159/000155642. Epub 2008 Sep 12.

Abstract

Background: Effective and safe products are needed for long-term management of scalp psoriasis. This study investigated the long-term safety and efficacy of a two-compound formulation (calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g) for scalp psoriasis.

Methods: In this 52-week, international, double-blind study, 869 patients with moderate-to-severe scalp psoriasis were randomized to either a two-compound scalp formulation (n = 429) or calcipotriol (n = 440).

Results: Adverse drug reactions were less frequent in the two-compound group compared with the calcipotriol group (17.2 vs. 29.5%; p < 0.001). Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2.6%) and the calcipotriol (3.0%) groups. Disease was satisfactorily controlled in 92.3% of visits in the two-compound group versus 80.0% in the calcipotriol group (p < 0.001).

Conclusion: The two-compound scalp formulation demonstrated a high level of safety and efficacy in long-term management of scalp psoriasis.

Publication types

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

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Betamethasone / adverse effects
  • Betamethasone / analogs & derivatives*
  • Betamethasone / therapeutic use
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Canada
  • Denmark
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Female
  • France
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Ointments
  • Pharmaceutical Vehicles
  • Prospective Studies
  • Psoriasis / drug therapy*
  • Scalp*
  • Severity of Illness Index
  • Treatment Outcome
  • United Kingdom

Substances

  • Anti-Inflammatory Agents
  • Dermatologic Agents
  • Drug Combinations
  • Ointments
  • Pharmaceutical Vehicles
  • calcipotriene
  • betamethasone-17,21-dipropionate
  • Betamethasone
  • Calcitriol