Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases

Not Applicable

• Conditions: Scleroderma, Systemic; Morphea; Graft Vs Host Disease

• Registration Number: NCT04922736
• Lead Sponsor: University of Utah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-6-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

<br><br> - Must be able to understand and provide written informed consent<br><br> - Must have a diagnosis of systemic scleroderma with cutaneous sclerosis, morphea, or<br> sclerodermatous Graft vs. host disease based on the presence of characteristic<br> clinical findings<br><br> - Age of at least 18-years-old<br><br> - Ability to engage in 30 UVA-1 treatments in a maximum of 100 days.<br><br>Exclusion criteria:<br><br> - Inability to complete study visits<br><br> - UV light therapy in the 4 weeks prior to entering the study<br><br> - Commercial tanning in the 4 weeks prior to entering the study<br><br> - Current pregnancy or planned pregnancy during the study period<br><br> - History of intolerance to ultraviolet light<br><br> - Any other condition that will disqualify the patient from the study in the opinion<br> of the investigator

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate change in the Health Assessment Questionnaire Disability Index (HAQ-DI) after 30 sessions of UVA-1 therapy in treating systemic Scleroderma, morphea, and sclerodermatous graft vs. host disease.

Secondary Outcome Measures

Name	Time	Method
Assess changes in the Hand Mobility in Scleroderma (HAMIS) score in patients with hand involvement after 30 sessions of UVA-1 therapy.;Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients after 30 sessions of UVA-1 therapy.;Assess changes in the Modified Rodnan Skin Score (mRSS) in systemic scleroderma patients after 30 sessions of UVA-1 therapy.;Assess changes in the National Institutes of Health (NIH) Likert scale score in GVHD patients after 30 sessions of UVA-1 therapy.;Assess changes in durometer scores in all patients after 30 sessions of UVA-1 therapy.