Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007306
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2000-12-16
Brief Title:
Treatment of Psoriasis With Parathyroid Hormone
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Evaluation of the Therapeutic Efficacy Safety of Topical Administration of Parathyroid Hormone PTH in Psoriasis
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical study in two phases The first phase compares the effect of an ointment containing parathyroid hormone PTH with the effect of a placebo ointment inactive ointment without PTH on psoriasis lesions Neither the study participants nor the researchers will know who is receiving PTH ointment and who is receiving placebo until the end of this first study phase The second phase is a study of the PTH ointment on large areas of psoriasis to find out how long the effects last
Detailed Description:
Patients with active plaque psoriasis will be withdrawn from systemic and topical medications After washout we will select active psoriatic lesions of at least 25 square cm in size to receive either placebo ointment or a proprietary ointment containing PTH for 8 weeks We will see the patients every 2 weeks We will evaluate the lesions by examination and digital photography at each visit and measure parameters of calcium metabolism periodically during the 8 weeks
At the conclusion of the 8 weeks we will obtain punch biopsies from the treated lesions and from one lesion without treatment If the patients elect we will transition them into an open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism
At the conclusion of the 8 weeks we will obtain punch biopsies from the treated lesions and from one lesion without treatment If the patients elect we will transition them into an open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism
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 |
|---|---|---|---|
| NIAMS-059 | None | None | None |