Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Northwestern University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004359

Purpose

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

II. Investigate the effect of ECP on lymphocyte activity.

Condition	Intervention	Phase
Epidermolysis Bullosa Acquisita	Drug: methoxsalen	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: epidermolysis bullosa simplex

Drug Information available for: Methoxsalen

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	10
Study Start Date:	February 1996

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

- Active epidermolysis bullosa acquisita

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004359

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Northwestern University

Investigators

Study Chair:

Kenneth B. Gordon

Northwestern University

More Information

No publications provided

Study ID Numbers:	199/11928, NU-511
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004359 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

dermatologic disorders
epidermolysis bullosa
genetic diseases and dysmorphic syndromes
rare disease

Study placed in the following topic categories:

Photosensitizing Agents
Radiation-Sensitizing Agents
Skin Diseases, Vesiculobullous
Genetic Diseases, Inborn
Skin Diseases
Methoxsalen

Skin Abnormalities
Rare Diseases
Epidermolysis Bullosa
Congenital Abnormalities
Skin Diseases, Genetic
Epidermolysis Bullosa Acquisita

Additional relevant MeSH terms:

Skin Diseases
Skin Diseases, Vesiculobullous
Physiological Effects of Drugs
Skin Abnormalities
Epidermolysis Bullosa
Pharmacologic Actions
Epidermolysis Bullosa Acquisita
Photosensitizing Agents

Genetic Diseases, Inborn
Radiation-Sensitizing Agents
Methoxsalen
Therapeutic Uses
Congenital Abnormalities
Dermatologic Agents
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on July 02, 2009