Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004359
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date  ICMJE October 18, 1999
First Posted Date  ICMJE October 19, 1999
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE February 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Epidermolysis Bullosa Acquisita
Intervention  ICMJE Drug: methoxsalen
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
10
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • Active epidermolysis bullosa acquisita
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004359
Other Study ID Numbers  ICMJE 199/11928
NU-511
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Research Resources (NCRR)
Collaborators  ICMJE Northwestern University
Investigators  ICMJE
Study Chair: Kenneth B. Gordon Northwestern University
PRS Account Office of Rare Diseases (ORD)
Verification Date January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP