Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
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Purpose
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 |
|---|---|
|
Psoriasis |
Drug: calcitriol |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| 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.
Eligibility| 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004468 History of Changes |
| Other Study ID Numbers: | 199/13927, BUSM-87-11, BUSM-87-011 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
dermatologic disorders psoriasis rare disease |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Calcitriol Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013