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Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis



Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis

For Condition: Psoriasis
Status: Suspended
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Boston University School of Medicine
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 500

Location and Contact Information:

Overall Study Official:
MichaelHolick,  Study Chair,  Boston University School of Medicine


Additional Information:
Study ID Numbers:  199/13927;  BUSM-87-11,BUSM-87-011
Study Start Date: October 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004468

Other Psoriasis Studies:
1. Micellar Paclitaxel to Treat Severe Psoriasis

2. Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis

3. To study the effects of CD25 and low dose Cyclosporin in the treatment of active Psoriasis vulgaris

4. A Pilot Study of Topical Antiflammin-2 for Psoriasis

5. The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases

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