UVA-1 Phototherapy Clinical Trial
A randomized, double-blinded, controlled trial of UVA-1 phototherapy in morphea funded by the Scleroderma Research Foundation grant. Please also see our Morphea in Adults and Children Cohort Study.
“Nothing in life is to be feared, it is only to be understood.” – Marie Curie
About the Trial
Who is eligible to join?
Anyone who meets the following criteria is eligible to join:
- Over 5 years of age
- One or more active morphea lesions
- No history of skin cancer or other photosensitive skin condition (e.g. lupus, porphyrias, polymorphic light eruption, xeroderma pigmentosum, etc.)
What does it cost?
There is no cost to participate in this UVA-1 study. Enrollment, laboratory testing, and treatment associated with the study are offered at no cost to you.
How do I join the study?
Contact us by email or phone to see if you are eligible.
Can I join both the UVA-1 trial and the morphea registry?
Yes! Most of our current trial participants are also involved with the morphea registry.
How much time will this take?
The initial screening and enrollment takes approximately one hour while the UVA-1 sessions average about 20 minutes in the phototherapy booth each time. There are a total of 30 phototherapy sessions with four additional follow-up clinic visits to check on progress. The first two follow-up sessions are often scheduled either before or after a phototherapy session (the last two take place after the completion of the 30 treatments).
Why is there a clinical trial if UVA-1 is already being used for morphea?
UVA-1 is a relatively new tool still considered an investigational (non-FDA approved) device used in the treatment of morphea. There have been several uncontrolled trials showing a possible benefit to using UVA-1 for morphea, but there have been no controlled trials to date. We are uniquely positioned to conduct this trial at UTSW because our group has both an established UVA-1 phototherapy unit and the national morphea registry onsite.
Why doesn’t everyone get the UVA-1 light?
A placebo group (or sham treatment group) is a necessary part of all placebo-controlled studies to account for the effects not directly caused by the treatment. For example, if five out of 10 people on the UVA-1 therapy improved without a control comparison group, it would seem like the UVA-1 therapy is working. However, if we had a comparison group that received no treatment and five out of their 10 also improve, we could say that the UVA-1 likely didn’t have any beneficial effect.
What happens if I end up in the placebo group?
At the end of the 30 treatments, the treatment group assignment will be revealed to both you and your providers. If you received the placebo, you will be offered active UVA-1 phototherapy at no cost. We will also monitor you closely. If you have significant worsening or increased problems related to morphea, we will start active treatments and remove you from the study.