A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp.

Abstract

BACKGROUND:

Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles.

OBJECTIVES:

To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.

METHODS:

Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.<BR>

RESULTS:

At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P <.001); a significant difference between groups was also observed at weeks 2 (P = .041) and 4 (P <.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P = .544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P = .019) and plaque thickness (P =.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema.

LIMITATIONS:

An 8-week study provides limited safety and efficacy data.<BR>

CONCLUSION:

Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.

• Authors: Steven R Feldman, Mary Mills, Thomas Brundage, William J Eastman
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 12 Issue 3 Pg. 300-6 (Mar 2013) ISSN: 1545-9616 [Print] United States
• PMID: 23545912 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dermatologic Agents
• calcipotriene
• Calcitriol

Topics

• Administration, Cutaneous
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Calcitriol (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Child
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Erythema (drug therapy, etiology)
• Female
• Humans
• Male
• Middle Aged
• Psoriasis (drug therapy, pathology)
• Scalp Dermatoses (drug therapy, pathology)
• Treatment Outcome
• Young Adult