- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01776190
Low-dose UVA1 Radiation in Cutaneous Lupus Patients
August 24, 2023 updated by: Ben Chong
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390-9069
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UVA1 treatment
Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin F Chong, MD, MSCS, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
August 30, 2012
First Submitted That Met QC Criteria
January 22, 2013
First Posted (Estimated)
January 28, 2013
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 072012-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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