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Low-dose UVA1 Radiation in Cutaneous Lupus Patients

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ClinicalTrials.gov Identifier: NCT01776190
Recruitment Status : Recruiting
First Posted : January 28, 2013
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Daavlin Corporation
Information provided by (Responsible Party):
Ben Chong, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE August 30, 2012
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date November 16, 2018
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
CLASI activity score [ Time Frame: 18 weeks ]
This is a measure of the amount of skin disease activity in cutaneous lupus patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01776190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Lupus flares [ Time Frame: 18 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose UVA1 Radiation in Cutaneous Lupus Patients
Official Title  ICMJE Low-dose UVA1 Radiation in Cutaneous Lupus Patients
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Lupus Erythematosus
Intervention  ICMJE Device: UVA1 radiation treatment
Study Arms  ICMJE Experimental: UVA1 treatment
Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks.
Intervention: Device: UVA1 radiation treatment
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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: Benjamin F Chong, MD, MSCS 214-648-3427 skinlupus.registry@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776190
Other Study ID Numbers  ICMJE 072012-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ben Chong, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE Ben Chong
Collaborators  ICMJE Daavlin Corporation
Investigators  ICMJE
Principal Investigator: Benjamin F Chong, MD, MSCS University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date November 2018

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