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Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis Clinical research trials and Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis. Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis clinical trial. Subjects typically recieve the finest healthcare available for their Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis  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. Characterizing Serum Protein Patterns in Selected Skin Diseases
2. To study the use of Humanized CD25 in preventing the relapse of Psoriasis Vulgaris
3. Study of Psoriatic Arthritis
4. Conditioning, the Placebo Effect, and Psoriasis
5. Micellar Paclitaxel to Treat Severe Psoriasis
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Study of Topical Calcitriol or Oral Calcitriol in Patients with Psoriasis
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