Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Daavlin Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVA1 treatment | Experimental | Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UVA1 radiation treatment | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin F Chong, MD, MSCS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9069 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | UVA1 Treatment | Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UVA1 Treatment | Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Cutaneous Lupus Erythematosus patients | Posted | Median | Inter-Quartile Range | Units on a scale | 10 weeks |
|
Adverse event data was collected over the 18 week observation period for each patient.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UVA1 Treatment | Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment |
Not provided
Not provided
Limitations include small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Chong, MD | University of Texas Southwestern Medical Center | 214-645-2400 | ben.chong@utsouthwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2012 | Aug 3, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | Units on a scale | 10 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
Not provided
Not provided