Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Not Applicable

Completed

• Conditions: Cutaneous Lupus Erythematosus
• Interventions: Device: UVA1 radiation treatment

• Registration Number: NCT01776190
• Lead Sponsor: Ben Chong

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 Timeline

• Study First Submitted: 2012-08-30
• Study Start: 2012-09
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-28
• Primary Completion: 2022-09
• Study Completion: 2022-09
• Status Verified: 2023-08
• Results First Submitted: 2023-08-03
• Results First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Results First Posted: 2023-08-25
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UVA1 treatment	UVA1 radiation treatment	Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score	10 weeks	The CLASI activity score represents the amount of skin disease activity in cutaneous lupus patients, as evaluated by a provider. The minimum score is 0 (no disease activity), and the maximum score is 70 (maximum/worst disease activity). The change is measured at the start and end of the UVA1 trial therapy.

Secondary Outcome Measures

Name	Time	Method
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score	10 weeks	The CLASI damge score represents the amount of skin disease damage in cutaneous lupus patients, as evaluated by a provider. The minimum score is 0 (no disease damage), and the maximum score is 80 (maximum/worst disease damage). The change is measured at the start and end of the UVA1 trial therapy.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States