Comparative study of calcipotriene (MC 903) ointment and fluocinonide ointment in the treatment of psoriasis.

Abstract

BACKGROUND:

The topical vitamin D analogue calcipotriene has been reported to be an effective treatment for patients with psoriasis. Comparative studies with topical steroids are informative in judging this new therapy.

OBJECTIVE:

The purpose of this study was to evaluate the efficacy and safety of calcipotriene ointment 0.005% versus fluocinonide ointment 0.05% in the treatment of plaque psoriasis.

METHODS:

This study was a randomized, double-blind, parallel-group, active-controlled trial in adults who had at least mild overall disease severity and plaque elevation of at least moderate severity. Treatments were applied twice daily for 6 weeks, and subjects were evaluated at weeks 0, 2, 4, and 6. Subjects were graded on a 9-point scale (0 to 8) for scaling, erythema, plaque elevation, and for overall disease severity. A physician's global assessment of improvement/worsening was performed at every visit.

RESULTS:

A total of 114 subjects were enrolled at six study sites. Ninety-nine subjects completed the trial. Mean scores for signs of scaling and plaque elevation in calcipotriene-treated subjects were significantly lower by week 2 than in the fluocinonide-treated subjects. These scores continued to be significantly lower than fluocinonide through week 6 (p < 0.05). Mean scores for erythema in calcipotriene-treated subjects were significantly lower than those in fluocinonide-treated subjects at weeks 4 and 6 (p < 0.05). Both the physician's global assessment and overall disease severity showed statistically significant treatment differences in favor of calcipotriene at week 4 (p < 0.05). This superior efficacy continued through week 6. Treatment-related adverse events were observed in 12 calcipotriene-treated subjects and 5 fluocinonide-treated subjects; all were considered minor.

CONCLUSION:

Calcipotriene was superior to fluocinonide in the treatment of plaque psoriasis.

• Authors: S Bruce, W W Epinette, T Funicella, A Ison, E L Jones, R Loss Jr, M E McPhee, C Whitmore
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 31 Issue 5 Pt 1 Pg. 755-9 (Nov 1994) ISSN: 0190-9622 [Print] United States
• PMID: 7929921 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dermatologic Agents
• Ointments
• calcipotriene
• Fluocinonide
• Calcitriol

Topics

• Adult
• Aged
• Calcitriol (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Fluocinonide (administration & dosage, adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Ointments
• Psoriasis (drug therapy, pathology)
• Safety
• Time Factors