A Randomized, Double-Blinded Trial Evaluating the Efficacy and Tolerability of Vectical Ointment (Calcitriol 3 mcg/g Ointment) When Compared to Betamethasone Diproprionate Ointment (64 mg/g) in Patients With Nail Psoriasis

August 2014 | Volume 13 | Issue 8 | Original Article | 912 | Copyright © 2014

Lauren Kole MD, Wendy Cantrell DNP, and Boni Elewski MD

Department of Dermatology, University of Alabama at Birmingham, Birmingham, AL

Abstract

OBJECTIVES: To demonstrate the efficacy and safety of calcitriol ointment (3 mcg/g) compared to betamethasone diproprionate ointment in the treatment of nail psoriasis.
DESIGN: Single-center, double-blind study.
SETTING: One academic center.
PARTICIPANTS: 10 adult male and female subjects with psoriasis of the fingernails and/or toenails.
MEASUREMENTS: The primary efficacy evaluation was the absolute reduction of nail thickness (mm) of the target nail. A secondary endpoint was the improvement in the Physician Global Assessment score of disease severity.
RESULTS: Patients treated with either betamethasone diproprionate ointment or calcitriol ointment demonstrated a similar reduction of nail thickness of the selected target nail. The difference between the two groups was not statistically significant (P=0.42).
CONCLUSION: This small study illustrates that calcitriol ointment may be as effective as betamethasone diproprionate in the treatment of nail psoriasis, and its promise should be further investigated in a subsequent larger trial.

J Drugs Dermatol. 2014;13(8):912-915.

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INTRODUCTION

Psoriasis is a chronic, incurable skin disease affecting millions of people worldwide. Nail abnormalities occur concomitantly in 50% of patients with psoriasis, with a lifetime incidence of 80% to 90 %.1 Nail psoriasis significantly impacts quality of life. In a survey of 1728 patients, 93% considered nail psoriasis a significant cosmetic handicap, 52% reported pain as a symptom, and 58% reported difficulty carrying out their job.2 The treatment of nail bed psoriasis poses a challenge to the clinician as there is a lack of controlled clinical trials and no gold standard of therapy to date. When nail bed psoriasis is not associated with widespread skin disease or psoriatic arthritis, topical treatment is typically the initial approach. Many physicians rely on topical and intralesional corticosteroids for treatment of nail bed disease (eg, onycholysis and subungual hyperkeratosis).3

However, the use of long-term, high potency corticosteroids has been associated with atrophy of the distal phalanx known as the “disappearing digit”.4, 5 Thus, safer treatment alternatives should be investigated. In a study by Tosti et al, the vitamin D analog calcipotriol was as effective as a corticosteroid preparation at reducing subungual hyperkeratosis in nail psoriasis.6 Another study of 24 patients by Zakeri et al, also showed that calcipotriol is effective in improving subungual hyperkeratosis, onycholysis, and discoloration. However, several patients in both studies complained of localized burning and irritation with calcipotriol therapy. Thus, patients would likely prefer a less irritating topical vitamin D analog. There are published reports demonstrating the increased tolerability of calcitriol ointment as compared to calciprotriol cream in the treatment of the sensitive intertriginous areas.7, 8 The aim of this study is to evaluate the efficacy and safety of calcitriol ointment (3 mcg/g) compared to betamethasone diproprionate ointment (64 mg/g) for treatment of nail bed psoriasis. The primary efficacy outcome is the absolute reduction is nail thickness (hyperkeratosis) as a measure of clinical improvement.

METHODS

Ten male and female subjects with nail psoriasis who were candidates for topical treatment were enrolled in this single center, double-blind 24-week study to examine the efficacy and safety of twice daily calcitriol ointment (3 mcg/g) compared to betamethasone diproprionate ointment (64 mg/g). The study protocol was reviewed and approved by the University of Alabama at Birmingham Institutional Review Board for Human Use. Subjects were required to have a history of plaque psoriasis with either fingernail or toenail involvement and at least one

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