Low-dose UVA1 Radiation in Cutaneous Lupus Patients

NCT01776190 | Completed Results

• 1 other identifier: 072012-024
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  10 weeks

Study Arms (1)

UVA1 treatment

EXPERIMENTAL

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

Device: UVA1 radiation treatment

Interventions

UVA1 radiation treatment DEVICE

UVA1 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ben Chong: lead
• Daavlin Corporation: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9069, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Limitations and Caveats

Limitations include small sample size

Results Point of Contact

• Title: Benjamin Chong, MD
• Organization: University of Texas Southwestern Medical Center

ben.chong@utsouthwestern.edu

214-645-2400

Study Officials

• Benjamin F Chong, MD, MSCS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: January 28, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2023-08

Locations

US (1)