Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Ben Chong

Status: Completed

Conditions: Cutaneous Lupus Erythematosus

Treatments: Device: UVA1 radiation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01776190

072012-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

UVA1 treatment

Experimental group

Description:

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

Treatment:

Device: UVA1 radiation treatment