Low-Dose UVA1 Radiation in Cutaneous Lupus Patients

Study ID
STU 072012-024

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact
Noelle Teske
801/556-6604
noelle.teske@utsouthwestern.edu

Principal Investigator
Benjamin Chong

Summary

This is an open-label trial to assess the efficacy, safety, and immunologic effects of uVa1 phototherapy on patients with cutaneous lupus erythematosus. Fifteen patients will be recruited to receive low dose (20 J/cm2) uVa1 phototherapy treatment three times per week for 10 weeks followed by an eight-week observation phase. in the event that a patient experiences adverse events (e.g. erythema) with the 20 J/cm2 dose, the dose will be decreased to 6 J/cm2. if symptoms persist, the patient will be withdrawn from the study. Patients will be allowed to continue on their current medications throughout the study. Patients will be assessed prior to, during, and at the end of uVa1 treatment at the end of the observation period. any adverse events and symptoms of SLe flares will be assessed simultaneously. Serological studies will be completed prior to treatment, during the treatment phase, and at the end of the observation phase. optional biopsies will be performed at the beginning and end of the active treatment phase. Gene and protein expression studies will be conducted on blood and skin samples with the intent of understanding the mechanism of action for uVa1 treatment in cutaneous lupus.

Participant Eligibility

1. Age > 18 years at enrollment.
2. Diagnosis of cutaneous lupus confirmed by clinicopathological correlation (DLE, SCLE x preferred)
3. CLASI activity score of >2
4. Stable dose of antimalarial for > 60 days.
5. Stable dose of immunosuppressive medications for > 30 days.
6. Stable use of topical medications for at least 30 days,
7. Able to speak and read English or Spanish at a 6th grade reading level.