Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

Phase 2

Completed

• Conditions: Epidermolysis Bullosa Acquisita

• Registration Number: NCT00004359
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief Summary

OBJECTIVES: I. Evaluate immunomodulation with extracorporeal photochemotherapy (ECP) in patients with epidermolysis bullosa acquisita.

II. Investigate the effect of ECP on lymphocyte activity.

Detailed 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.

Study Timeline

• Study Start: 1996-02
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2000-01
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified