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Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Primary Purpose

Cutaneous Lupus Erythematosus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UVA1 radiation treatment

About this trial

This is an interventional treatment trial for Cutaneous Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UVA1 treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01776190

First Posted

August 30, 2012

Last Updated

August 24, 2023

Sponsor

Ben Chong

Collaborators

Daavlin Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01776190

Brief Title

Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Official Title

Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2022 (Actual)

Study Completion Date

September 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ben Chong

Collaborators

Daavlin Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UVA1 treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

UVA1 radiation treatment

Primary Outcome Measure Information:

Title

Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score

Description

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score

Description

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin F Chong, MD, MSCS

Organizational Affiliation

University of Texas Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9069

Country

United States

12. IPD Sharing Statement

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Low-dose UVA1 Radiation in Cutaneous Lupus Patients

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