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

NCT04922736 | Active Not Recruiting FDA Device

• 1 other identifier: IRB_00142027
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Systemic; Morphea; Graft Vs Host Disease

Outcome Measures

Primary Outcomes (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.

  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).

  100 days

Secondary Outcomes (5)

• Assess changes in the Hand Mobility in Scleroderma (HAMIS) score in patients with hand involvement after 30 sessions of UVA-1 therapy.

  100 days

• Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients after 30 sessions of UVA-1 therapy.

  100 days

• Assess changes in the Modified Rodnan Skin Score (mRSS) in systemic scleroderma patients after 30 sessions of UVA-1 therapy.

  100 days

• Assess changes in the National Institutes of Health (NIH) Likert scale score in GVHD patients after 30 sessions of UVA-1 therapy.

  100 days

• Assess changes in durometer scores in all patients after 30 sessions of UVA-1 therapy.

  100 days

Interventions

UVA-1 Phototherapy DEVICE

All patients will receive UVA-1 Phototherapy treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Dermatology

Murray, Utah, 84132, United States

Location

Related Publications (13)

• Kreuter A, Hyun J, Stucker M, Sommer A, Altmeyer P, Gambichler T. A randomized controlled study of low-dose UVA1, medium-dose UVA1, and narrowband UVB phototherapy in the treatment of localized scleroderma. J Am Acad Dermatol. 2006 Mar;54(3):440-7. doi: 10.1016/j.jaad.2005.11.1063. Epub 2006 Jan 30.

  PMID: 16488295 BACKGROUND

• Hassani J, Feldman SR. Phototherapy in Scleroderma. Dermatol Ther (Heidelb). 2016 Dec;6(4):519-553. doi: 10.1007/s13555-016-0136-3. Epub 2016 Aug 12.

  PMID: 27519050 BACKGROUND

• Poole JL, Steen VD. The use of the Health Assessment Questionnaire (HAQ) to determine physical disability in systemic sclerosis. Arthritis Care Res. 1991 Mar;4(1):27-31. doi: 10.1002/art.1790040106.

  PMID: 11188583 BACKGROUND

• Filippetti M, Cazzoletti L, Zamboni F, Ferrari P, Caimmi C, Smania N, Tardivo S, Ferrari M. Effect of a tailored home-based exercise program in patients with systemic sclerosis: A randomized controlled trial. Scand J Med Sci Sports. 2020 Sep;30(9):1675-1684. doi: 10.1111/sms.13702. Epub 2020 May 11.

  PMID: 32350931 BACKGROUND

• Khanna D, Spino C, Johnson S, Chung L, Whitfield ML, Denton CP, Berrocal V, Franks J, Mehta B, Molitor J, Steen VD, Lafyatis R, Simms RW, Gill A, Kafaja S, Frech TM, Hsu V, Domsic RT, Pope JE, Gordon JK, Mayes MD, Schiopu E, Young A, Sandorfi N, Park J, Hant FN, Bernstein EJ, Chatterjee S, Castelino FV, Ajam A, Wang Y, Wood T, Allanore Y, Matucci-Cerinic M, Distler O, Singer O, Bush E, Fox DA, Furst DE. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):125-136. doi: 10.1002/art.41055. Epub 2019 Dec 10.

  PMID: 31342624 BACKGROUND

• Kreuter A, Breuckmann F, Uhle A, Brockmeyer N, Von Kobyletzki G, Freitag M, Stuecker M, Hoffmann K, Gambichler T, Altmeyer P. Low-dose UVA1 phototherapy in systemic sclerosis: effects on acrosclerosis. J Am Acad Dermatol. 2004 May;50(5):740-7. doi: 10.1016/j.jaad.2003.08.026.

  PMID: 15097958 BACKGROUND

• Gambichler T, Schmitz L. Ultraviolet A1 Phototherapy for Fibrosing Conditions. Front Med (Lausanne). 2018 Aug 27;5:237. doi: 10.3389/fmed.2018.00237. eCollection 2018.

  PMID: 30211165 BACKGROUND

• Skrzypek-Salamon A, Lis-Swiety A, Ranosz-Janicka I, Brzezinska-Wcislo L. Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) adapted for use in adult patients: report from an initial validation study. Health Qual Life Outcomes. 2018 Sep 14;16(1):185. doi: 10.1186/s12955-018-1010-z.

  PMID: 30217204 BACKGROUND

• Khanna D, Furst DE, Clements PJ, Allanore Y, Baron M, Czirjak L, Distler O, Foeldvari I, Kuwana M, Matucci-Cerinic M, Mayes M, Medsger T Jr, Merkel PA, Pope JE, Seibold JR, Steen V, Stevens W, Denton CP. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord. 2017 Jan-Apr;2(1):11-18. doi: 10.5301/jsrd.5000231.

  PMID: 28516167 BACKGROUND

• Lee SJ, Wolff D, Kitko C, Koreth J, Inamoto Y, Jagasia M, Pidala J, Olivieri A, Martin PJ, Przepiorka D, Pusic I, Dignan F, Mitchell SA, Lawitschka A, Jacobsohn D, Hall AM, Flowers ME, Schultz KR, Vogelsang G, Pavletic S. Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report. Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99. doi: 10.1016/j.bbmt.2015.02.025. Epub 2015 Mar 19.

  PMID: 25796139 BACKGROUND

• Sandqvist G, Eklund M. Hand Mobility in Scleroderma (HAMIS) test: the reliability of a novel hand function test. Arthritis Care Res. 2000 Dec;13(6):369-74.

  PMID: 14635312 BACKGROUND

• Steen VD, Medsger TA Jr. The value of the Health Assessment Questionnaire and special patient-generated scales to demonstrate change in systemic sclerosis patients over time. Arthritis Rheum. 1997 Nov;40(11):1984-91. doi: 10.1002/art.1780401110.

  PMID: 9365087 BACKGROUND

• Allanore Y, Bozzi S, Terlinden A, Huscher D, Amand C, Soubrane C, Siegert E, Czirjak L, Carreira PE, Hachulla E, Zanatta E, Li M, Airo P, Mendoza FA, Rosato E, Distler O; EUSTAR Collaborators. Health Assessment Questionnaire-Disability Index (HAQ-DI) use in modelling disease progression in diffuse cutaneous systemic sclerosis: an analysis from the EUSTAR database. Arthritis Res Ther. 2020 Oct 28;22(1):257. doi: 10.1186/s13075-020-02329-2.

  PMID: 33115544 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Localized; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Immune System Diseases

Study Officials

• Christopher B. Hansen, M.D.

  University of Utah MidValley Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dermatology, Principal Investigator

Model Details: Single Group, open label,

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 11, 2021
• Study Start: June 7, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)