Low-dose UVA1 Radiation in Cutaneous Lupus Patients
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.
|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|
- 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.
- 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.
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776190
|Contact: Benjamin F Chong, MD, MSCSfirstname.lastname@example.org|
|Contact: Patrick Blake, MDemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Patrick Blake, MD 214-645-8971 email@example.com|
|Principal Investigator:||Benjamin F Chong, MD, MSCS||University of Texas Southwestern Medical Center|