N/A
N=6
Low-dose UVA1 Radiation in Cutaneous Lupus Patients
Cutaneous Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT01776190 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score — -1 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UVA1 radiation treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ben Chong
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score |
-1 | — |
| SECONDARY Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01776190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.