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Low-dose UVA1 Radiation in Cutaneous Lupus Patients

This study is currently recruiting participants.
Verified January 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Daavlin Corporation
Information provided by (Responsible Party):
Ben Chong, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01776190
First received: August 30, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators are conducting an open-label clinical trial determining the effects of UVA1 phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE) subjects indicates that this treatment is likely to be effective in treating cutaneous lupus with few side effects. The fact that most CLE patients are seen at dermatology clinics also increases the usefulness of this study because there is a large probability that phototherapy treatment will be accessible for many of the patients that stand to benefit from it.


Condition Intervention
Cutaneous Lupus Erythematosus
 Device: UVA1 radiation treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • CLASI activity score [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    This is a measure of the amount of skin disease activity in cutaneous lupus patients.


Secondary Outcome Measures:
  • Lupus flares [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
    We are determining whether one has a cutaneous lupus or systemic lupus flare with this treatment. Measurements using the Cutaneous Lupus Activity and Severity Index and Systemic Lupus Erythematosus Disease Activity Index will be used to monitor disease activity and help determine flares.


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UVA1 treatment
Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks.
 Device: UVA1 radiation treatment

Detailed Description:

Study subjects will receive low dose (20 J/cm2) UVA1 phototherapy treatment three times per week for 10 weeks. Each treatment will take less than 30 minutes. This period will be followed by an eight-week observation phase to assess longer term effects of the treatment. Patients will be assessed for disease activity, and blood studies and photos will be completed prior to, during, and after phototherapy treatment. Optional skin biopsies of affected and unaffected skin will be performed at the beginning and end of the active treatment phase.

  Eligibility

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

Inclusion Criteria:

  • You must be 18 years or older with a diagnosis of cutaneous lupus.
  • You must have at least two active areas of cutaneous lupus.
  • You will need to come in three days a week for a 10-week period.
  • You will need to participate in four physician visits and blood draws.

Exclusion Criteria:

  • You do not have a diagnosis of cutaneous lupus.
  • You have less than two active areas of cutaneous lupus.
  • You are unable to come in three days a week for treatment for a 10-week period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776190

Contacts
Contact: Benjamin F Chong, MD, MSCS 214-645-8971 skinlupus.registry@utsouthwestern.edu
Contact: Patrick Blake, MD 214-645-8971 skinlupus.registry@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9069
Contact: Benjamin F Chong, MD, MSCS     214-645-8971     skinlupus.registry@utsouthwestern.edu    
Contact: Patrick Blake, MD     214-645-8971     skinlupus.registry@utsouthwestern.edu    
Sponsors and Collaborators
Ben Chong
Daavlin Corporation
Investigators
Principal Investigator: Benjamin F Chong, MD, MSCS University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Ben Chong, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01776190     History of Changes
Other Study ID Numbers: 072012-024
Study First Received: August 30, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Connective Tissue Diseases
 Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013