Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
Overview[ - collapse ][ - ]
| 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 | Psoriasis |
| Intervention | Drug: calcitriol |
| Phase | N/A |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Responsible Party | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier | NCT00004468 |
| First Received | October 18, 1999 |
| Last Updated | June 23, 2005 |
| Last verified | July 2004 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 18, 1999 |
|---|---|
| Last Updated Date | June 23, 2005 |
| Start Date | October 1998 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis |
|---|---|
| Official Title | Not Provided |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment |
| Condition | Psoriasis |
| Intervention | Drug: calcitriol |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 500 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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 |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00004468 |
|---|---|
| Other Study ID Numbers | 199/13927 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Office of Rare Diseases (ORD) |
| Study Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Collaborators | Boston University |
| Investigators | Study Chair: Michael F. Holick Boston University |
| Verification Date | July 2004 |