Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Cutaneous Lupus Erythematosus Clinical Trial

Official title:

Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776190
• Other study ID #: 072012-024
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2022

Study information

• Verified date: August 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous

Intervention

Device:
• UVA1 radiation treatment

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Ben Chong	Daavlin Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score	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.	10 weeks
Secondary	Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score	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.	10 weeks