Low-dose UVA1 Radiation in Cutaneous Lupus Patients

NCT ID: NCT01776190

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2022-09-30

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.

Conditions

Cutaneous Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UVA1 treatment

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

Group Type: EXPERIMENTAL

UVA1 radiation treatment

Intervention Type: DEVICE

Interventions

UVA1 radiation treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daavlin Corporation

INDUSTRY

Sponsor Role: collaborator

Ben Chong

OTHER

Sponsor Role: lead

Responsible Party

Ben Chong

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Benjamin F Chong, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

072012-024

Identifier Type: -

Identifier Source: org_study_id