UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma

Not Applicable

• Conditions: Scleroderma

• Registration Number: NCT04875078
• Lead Sponsor: University of Utah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:<br><br> - Must be able to understand and provide written informed consent<br><br> - Scleroderma skin involvement affecting both hands approximately equally<br><br> - Age of at least 18-years-old<br><br> - Male or female<br><br> - Ability to engage in twice weekly UVA1 sessions<br><br> - No changes in systemic therapy during the first 100 days of the study period<br><br>Exclusion Criteria:<br><br> - On photosensitizing medication<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 or excessive sun exposure in the 4 weeks prior to entering the<br> study<br><br> - Current pregnancy or planned pregnancy during the study period<br><br> - Use of topical therapies other than emollients (suprapotent corticosteroids) in the<br> 2 weeks prior to entering the study<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
HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed.

Secondary Outcome Measures

Name	Time	Method
Change in HAMIS score from baseline to after 30 UVA-1 treatments of treated hand.;Change in CHFDS score from baseline to after 30 UVA-1 treatments of treated hand.;Change in skin hardness from baseline to after 30 UVA-1 treatments of treated hand.;Change in skin thickness from baseline to after 30 UVA-1 treatments of treated hand.;Change in Skindex-16 score from baseline to after 30 UVA-1 treatments of treated hand.;Change in MHQ scores from baseline to after 30 UVA-1 treatments of treated hand.;Change in HDISS-DU from baseline to after 30 UVA-1 treatments of treated hand.;Change in PROMIS-PF scores from baseline to after 30 UVA-1 treatments of treated hand.