PMID- 19445311
OWN - NLM
STAT- MEDLINE
DCOM- 20090605
LR  - 20131121
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 83
IP  - 4
DP  - 2009 Apr
TI  - Calcitriol ointment 3 microg/g is safe and effective over 52 weeks for the 
      treatment of mild to moderate plaque psoriasis.
PG  - 205-12
AB  - Topical vitamin D3 agents have emerged as important options for the treatment of 
      psoriasis. Calcitriol, a naturally occurring and biologically active form of 
      vitamin D3, has been developed in an ointment formulation for topical psoriasis 
      therapy in the United States. The product has been used outside of the United 
      States for years. Several short-term (< 6 months) clinical trials have 
      demonstrated that calcitriol ointment 3 microg/g improves symptoms of psoriasis 
      in participants with mild to moderate plaque psoriasis without demonstrating 
      clinical evidence of alterations in calcium homeostasis, but little information 
      has been available about the safety and effectiveness of continuous long-term use 
      of calcitriol ointment. In this open-label, multicenter study, 324 participants 
      with primarily mild to moderate chronic plaque psoriasis were treated with 
      calcitriol ointment 3 microg/g twice daily for up to 52 weeks. A total of 136 
      participants completed 52 weeks of treatment. Serious adverse events (AEs) 
      (reported by 1 participant each unless otherwise noted) included a pretibial skin 
      ulcer (study drug was used only on the upper body), a joint disorder, 
      metrorrhagia (2 participants), heart failure, hospitalization due to 
      arteriosclerosis, breast carcinoma, and an infection (due to a dog bite). 
      Clinical improvement in psoriasis symptoms was assessed by an investigator-rated 
      global severity score (GSS) and participant-rated global assessment of 
      improvement in psoriasis symptoms from baseline. Improvements in GSS were seen 
      over the course of treatment. Calcitriol ointment 3 microg/g is a safe, 
      effective, and well-tolerated option for the long-term treatment of chronic 
      plaque psoriasis. Clinical improvement was maintained for up to 52 weeks, with no 
      clinical effect on calcium homeostasis or other relevant laboratory test 
      parameters.
FAU - Lebwohl, Mark
AU  - Lebwohl M
AD  - Mount Sinai School of Medicine, New York, NY 10029, USA. lebwohl@aol.com
FAU - Ortonne, Jean-Paul
AU  - Ortonne JP
FAU - Andres, Philippe
AU  - Andres P
FAU - Briantais, Philippe
AU  - Briantais P
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Ointments)
RN  - 0 (Vitamins)
RN  - FXC9231JVH (Calcitriol)
SB  - IM
MH  - Adolescent
MH  - Calcitriol/*administration & dosage
MH  - Child
MH  - Female
MH  - Humans
MH  - Male
MH  - Ointments
MH  - Psoriasis/*drug therapy
MH  - Vitamins/*administration & dosage/adverse effects
EDAT- 2009/05/19 09:00
MHDA- 2009/06/09 09:00
CRDT- 2009/05/19 09:00
PHST- 2009/05/19 09:00 [entrez]
PHST- 2009/05/19 09:00 [pubmed]
PHST- 2009/06/09 09:00 [medline]
PST - ppublish
SO  - Cutis. 2009 Apr;83(4):205-12.