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Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
This study has been completed.
Study NCT00004468   Information provided by Office of Rare Diseases (ORD)
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes

October 18, 1999
June 23, 2005
October 1998
 
 
 
Complete list of historical versions of study NCT00004468 on ClinicalTrials.gov Archive Site
 
 
 
Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
 

OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis.

II. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis.

III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

PROTOCOL OUTLINE: This is a part placebo-controlled (arm I) study. Patients either apply topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily and petrolatum only on an other similar lesion daily to serve as a control (arm I) or receive oral calcitriol nightly (arm II).

Arm I patients continue treatment for at least 2 months. At the end of 2 months of topical treatment, one biopsy is taken of the lesion treated with calcitriol, one biopsy of the lesion treated with petrolatum alone, and one biopsy of skin unaffected by psoriasis. Lesions are also photographed prior to therapy, 2-4 weeks during therapy for the first two months, then once every 1-3 months, and then once at end of treatment.

Arm II patients increase dosage of oral calcitriol every 2 weeks up to a maximum dosage daily in the absence of adverse effects (high urinary calcium or serum calcium levels). Patients continue treatment for at least 1 month. Lesions are photographed prior to therapy, 2-4 weeks during therapy, and then once at end of treatment.

 
Interventional
Treatment, Safety/Efficacy Study
Psoriasis
Drug: calcitriol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
500
 
 

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Psoriasis covering at least 5% of body

--Prior/Concurrent Therapy--

At least 30 days since prior systemic therapy for psoriasis

At least 14 days since prior topical therapy for psoriasis

No other concurrent treatment for psoriasis for the first 2-4 months of study

No calcium supplement greater than 1,000 mg per day

--Patient Characteristics--

No hypercalcemia

No hypercalciuria

Not pregnant

Effective contraception required of all fertile patients

Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004468
 
199/13927, BUSM-87-11, BUSM-87-011
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston University
Study Chair: Michael F. Holick Boston University
Office of Rare Diseases (ORD)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP