Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004468
Status:
WITHDRAWN
Last Update Posted:
2018-03-02
First Post:
1999-10-18
Brief Title:
Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BUSM-87-011 | OTHER | None | None |
| R01DK043690 | NIH | Boston University School of Medicine | httpsreporternihgovquickSearchR01DK043690 |