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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Boston University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004468 |
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.
Condition | Intervention |
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Psoriasis |
Drug: calcitriol |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Estimated Enrollment: | 500 |
Study Start Date: | October 1998 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | 199/13927, BUSM-87-11, BUSM-87-011 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004468 |
Health Authority: | United States: Federal Government |
dermatologic disorders psoriasis rare disease |
Calcium, Dietary Skin Diseases Psoriasis |
Rare Diseases Skin Diseases, Papulosquamous Calcitriol |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Growth Substances Vitamins Calcium Channel Agonists |
Physiological Effects of Drugs Vasoconstrictor Agents Bone Density Conservation Agents Cardiovascular Agents Micronutrients Pharmacologic Actions |