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Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004359
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Acquisita
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
 Methoxsalen
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013