Cutaneous Lupus Erythematosus
Conditions
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.
Interventions
DEVICEUVA1 radiation treatment
Sponsors
Daavlin Corporation
Ben Chong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UVA1 Treatment Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks.
UVA1 radiation treatment | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | UVA1 Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 37.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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.
Time frame: 10 weeks
Population: Cutaneous Lupus Erythematosus patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UVA1 Treatment | Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score | -1 Units on a scale |
Secondary
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.
Time frame: 10 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UVA1 Treatment | Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score | 0 Units on a scale |