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OpenTrials
Completed

NCT Number: NCT01776190

Low-dose UVA1 Radiation in Cutaneous Lupus Patients

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.

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Key information

Conditions

Cutaneous Lupus Erythematosus Connective Tissue Diseases Lupus Erythematosus, Cutaneous Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9069, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UVA1 radiation treatment

Device

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ben Chong

Other

Collaborators

  • Daavlin Corporation

Registry information

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2013
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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