← Back to all trials
Active Not Recruiting
NCT04922736
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Conditions: Scleroderma, Systemic, Morphea, Graft Vs Host Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University of Utah
Location: University of Utah Dermatology Murray Utah
Summary
The purpose of this study is to assess the degree of improvement seen patient reported outcomes after 30 sessions of UVA-1 therapy in treating systemic scleroderma, morphea, and sclerodermatous Graft-Versus-Host Disease.
While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, patient reported outcomes have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, patient reported outcomes may offer a better way to study the impact of treatments like UVA-1.
This will be a non-blinded, non-randomized prospective trial using UVA-1 phototherapy in patients with established sclerosing skin disease. Patients will report the severity of their condition using multiple patient reported outcomes and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions.
Eligibility Criteria
Inclusion criteria:
* Must be able to understand and provide written informed consent
* Must have a diagnosis of systemic scleroderma with cutaneous sclerosis, morphea, or sclerodermatous Graft vs. host disease based on the presence of characteristic clinical findings
* Age of at least 18-years-old
* Ability to engage in 30 UVA-1 treatments in a maximum of 100 days.
Exclusion criteria:
* Inability to complete study visits
* UV light therapy in the 4 weeks prior to entering the study
* Commercial tanning in the 4 weeks prior to entering the study
* Current pregnancy or planned pregnancy during the study period
* History of intolerance to ultraviolet light
* Any other condition that will disqualify the patient from the study in the opinion of the investigator
Source: ClinicalTrials.gov (NCT04922736). StuddyBuddy aggregates publicly available trial information.