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

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ClinicalTrials.gov Identifier: NCT04922736
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Christopher B Hansen, University of Utah

Brief 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.


Condition or disease Intervention/treatment Phase
Scleroderma, Systemic Morphea Graft Vs Host Disease Device: UVA-1 Phototherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group, open label,
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : September 2023



Intervention Details:
  • Device: UVA-1 Phototherapy
    All patients will receive UVA-1 Phototherapy treatments


Primary Outcome Measures :
  1. 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. [ Time Frame: 100 days ]
    The Health Assessment Questionnaire Disability Index (HAQ-DI) is a validated patient self-administered tool used to assess changes in disease activity, especially the skin involvement in SSc (Steen, 1997). The questionnaire consists of 20 items in eight domains related to measuring the difficulty of performing activities of daily living, with each question rated on a scale of 0-3; 0 indicates "without difficulty" and 3 indicates "unable to do" (Allanore 2020).


Secondary Outcome Measures :
  1. Assess changes in the Hand Mobility in Scleroderma (HAMIS) score in patients with hand involvement after 30 sessions of UVA-1 therapy. [ Time Frame: 100 days ]
    HAMIS is a hand function test developed for adults with SSc and consists of 9 items designed to measure all movements assessed in an ordinary range of motion (ROM)-measured hand test. Specific items test finger flexion and extension, thumb abduction, pincer grip, finger abduction/swelling, dorsal extension and volar extension of the wrist, and pronation and supination. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The minimum score for HAMIS is 0, representing normal hand function. The maximum score is 27, representing a high degree of dysfunction (Sandqvist, 2000).

  2. Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients after 30 sessions of UVA-1 therapy. [ Time Frame: 100 days ]
    The Localized Scleroderma Assessment Tool (LoSCAT) is a reliable tool to capture morphea disease activity and damage by assessing skin thickness, erythema, and new lesions/lesion extension. This tool assesses 18 different body locations using a 0-3 point scale, where 0 indicates no disability and 3 indicates complete disability (Skrzypek-Salamon, 2018). The score is calculated by adding the scores at each site to equal a total score ranging from 0 (normal) to 54 (severe disease).

  3. Assess changes in the Modified Rodnan Skin Score (mRSS) in systemic scleroderma patients after 30 sessions of UVA-1 therapy. [ Time Frame: 100 days ]
    The physician assessment on skin thickness based on the modified Rodnan skin score (mRSS) is a standard outcome measure for skin disease in systemic sclerosis. The score is calculated by evaluating the skin thickness at 17 different body sites. Each site is graded from 0 to 3, with 0 representing normal skin and 3 representing severe skin thickness. The score is calculated by adding the scores at each site to arrive at a total score ranging from 0 (normal) to 51 (severe disease) (Khanna, 2017).

  4. Assess changes in the National Institutes of Health (NIH) Likert scale score in GVHD patients after 30 sessions of UVA-1 therapy. [ Time Frame: 100 days ]
    The NIH severity score was created for assessing organ involvement in GVHD. Sclerotic skin disease is rated on an 11-point (0- to 10-point scale), clinician-reported assessment of disease severity (Lee, 2015). We will use this method and limit the assessment of patients with GVHD to a single clinician to eliminate interrater variability.

  5. Assess changes in durometer scores in all patients after 30 sessions of UVA-1 therapy. [ Time Frame: 100 days ]
    A Durometer is an instrument used to test the hardness of various materials. It has been used in scleroderma to compare the hardness of affected skin vs. normal skin. We will take an average of three durometry measurements at each of the involved sites.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922736


Locations
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United States, Utah
University of Utah Dermatology
Murray, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Christopher B. Hansen, M.D. University of Utah MidValley Dermatology
Publications:

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Responsible Party: Christopher B Hansen, Assistant Professor, Dermatology, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04922736    
Other Study ID Numbers: IRB_00142027
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Skin Diseases
Scleroderma, Localized
Graft vs Host Disease
Connective Tissue Diseases
Immune System Diseases