A new scalp formulation of calcipotriene plus betamethasone compared with its active ingredients and the vehicle in the treatment of scalp psoriasis: a randomized, double-blind, controlled trial

J Am Acad Dermatol. 2008 Sep;59(3):455-63. doi: 10.1016/j.jaad.2008.04.027.

Abstract

Background: New topical treatments in scalp psoriasis are needed because many current topical treatments are disliked by patients and associated with poor compliance.

Objective: To compare the efficacy and safety of once-daily, two-compound scalp formulation containing calcipotriene plus betamethasone dipropionate with the individual components in the same vehicle and the vehicle alone.

Methods: In this 8-week, multicenter, randomized, double-blind study, patients with scalp psoriasis were randomized to treatment with the two-compound scalp formulation (calcipotriene 50 microg/g plus betamethasone 0.5 mg/g, as dipropionate) (n = 541), betamethasone 0.5 mg/g (as dipropionate) in the same vehicle (n = 556), calcipotriene 50 microg/g in the same vehicle (n = 272), or vehicle alone (n = 136).

Results: More patients achieved "absent" or "very mild" disease at week 8 with the two-compound scalp formulation (71.2%) compared with betamethasone dipropionate in the same vehicle (64.0%, p = .011), calcipotriene in the same vehicle (36.8%, p < .0001), or the vehicle (22.8%, p < .0001).

Limitations: Efficacy of the active comparators in the study has not been established in relation to calcipotriene and betamethasone formulations available for clinical use.

Conclusion: Calcipotriene plus betamethasone dipropionate scalp formulation was more effective than either of the individual components or the vehicle alone.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents / administration & dosage*
  • Betamethasone / administration & dosage
  • Betamethasone / adverse effects
  • Betamethasone / analogs & derivatives*
  • Calcitriol / administration & dosage
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Dermatologic Agents / administration & dosage*
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pharmaceutical Vehicles
  • Psoriasis / drug therapy*
  • Psoriasis / pathology
  • Scalp Dermatoses / drug therapy*
  • Scalp Dermatoses / pathology
  • Severity of Illness Index
  • Skin / pathology
  • Treatment Outcome

Substances

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