Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

NCT ID: NCT00004359

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-02-29

Brief Summary

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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

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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.

Conditions

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Epidermolysis Bullosa Acquisita

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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methoxsalen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active epidermolysis bullosa acquisita
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Kenneth B. Gordon

Role: STUDY_CHAIR

Northwestern University

Other Identifiers

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NU-511

Identifier Type: -

Identifier Source: secondary_id

199/11928

Identifier Type: -

Identifier Source: org_study_id