Calcipotriene ointment 0.005% for psoriasis: a safety and efficacy study. 
Calcipotriene Study Group.

Abstract: BACKGROUND: Plaque psoriasis of mild to moderate severity is routinely treated 
with topical steroids and coal tar along with emollients. A safe and convenient new treatment 
modality would be of value to most patients with psoriasis. OBJECTIVE: Our purpose was to 
evaluate the safety and efficacy of a new vitamin D3 analogue, calcipotriene, for the 
treatment of plaque psoriasis. METHODS: Twice-daily dosing of calcipotriene was 
compared with its vehicle, for up to 8 weeks, in a double-blind study of 277 patients at 10 study 
centers in the United States. Two hundred forty-seven patients completed the trial. The 
clinical characteristics of plaque elevation, erythema, scaling, and overall disease severity 
were evaluated at baseline and after 1, 2, 4, 6, and 8 weeks of treatment. A Physician's Global 
Assessment of improvement or worsening of the disease was performed after 1, 2, 4, 6, and 8 
weeks of treatment. Blood and urine samples, for routine clinical laboratory tests, were 
collected at baseline and after 1, 2, 4, and 8 weeks of treatment. RESULTS: As early as the 
week 1 evaluation, patients treated with calcipotriene ointment 0.005% had significantly 
lower mean scores (p = 0.043) than the vehicle-treated patients for the disease characteristics 
of plaque elevation, erythema, and scaling. This trend continued through week 8 of treatment 
when 70% of the calcipotriene-treated patients showed 75% or more improvement compared 
with only 19% of vehicle-treated patients. Only minor treatment-related adverse events were 
observed. There were no abnormal laboratory results judged related to treatment and the 
rare instances of elevated serum calcium values were equally distributed between active and 
vehicle treatments. CONCLUSION: This study provides evidence that calcipotriene is a safe, 
effective, and promising new agent for the treatment of moderately severe plaque psoriasis.
Author:  
¥Highton A 
¥Quell J 
Address: Bristol-Myers Squibb Co., Buffalo, NY 14213.
Abbreviated Journal Title: J Am Acad Dermatol
Date Of Publication: 1995 Jan
Journal Volume: 32
Page Numbers:  67 through 72 
Country of Publication: UNITED STATES
Language of Article: Eng
Issue/Part/Supplement: 1
ISSN: 0190-9622
MESH Headings:  
¥Administration, Cutaneous 
¥Adult 
¥Aged 
¥Aged, 80 and over 
¥Calcitriol (Central Concept) 
¥Dermatologic Agents (Central Concept) 
¥Double-Blind Method 
¥Female 
¥Human 
¥Male 
¥Middle Age 
¥Ointments 
¥Psoriasis (Central Concept) 
¥Time Factors 
¥Treatment Outcome 
¥United States 
Chemical Abstract Service Registry Number:  
¥0 (Dermatologic Agents) 
¥0 (Ointments) 
¥112965-21-6 (calcipotriene) 
¥32222-06-3 (Calcitriol) 
Article ID: 95122773