Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00004359 |
| Other study ID # |
199/11928 |
| Secondary ID |
NU-511 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
October 18, 1999 |
| Last updated |
June 23, 2005 |
| Start date |
February 1996 |
Study information
| Verified date |
January 2000 |
| Source |
Office of Rare Diseases (ORD) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
OBJECTIVES: I. Evaluate immunomodulation with extracorporeal photochemotherapy (ECP) in
patients with epidermolysis bullosa acquisita.
II. Investigate the effect of ECP on lymphocyte activity.
Description:
PROTOCOL OUTLINE: Oral methoxsalen (8-MOP) is administered 90 minutes prior to
leukapheresis. Blood mononuclear cells are exposed to ultraviolet A light for 3 hours, then
returned to the patient. The process is repeated on 2 successive days.
Patients are re-treated every 3 to 4 weeks for a total of 6 treatments or until the skin has
cleared.
