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Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

Primary Purpose

Epidermolysis Bullosa Acquisita

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
methoxsalen
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa Acquisita focused on measuring dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Active epidermolysis bullosa acquisita

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004359
    Brief Title
    Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Northwestern University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epidermolysis Bullosa Acquisita
    Keywords
    dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    10 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    methoxsalen

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Active epidermolysis bullosa acquisita
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth B. Gordon
    Organizational Affiliation
    Northwestern University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

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