Scleroderma, SystemicNCT04922736
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
A study testing UVA-1 Phototherapy in people with Scleroderma, Systemic and Morphea, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic, Morphea, Graft Vs Host Disease
- What is being tested?
- UVA-1 Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Ultraviolet (UV) therapy has been used in dermatology for decades. UVA-1 phototherapy uses the longest wavelengths in the UV spectrum from 340-400 nm. It can penetrate the skin deeper than other types of phototherapy and target different cell types including fibroblasts. In sclerosing skin conditions UVA-1 appears to be superior to other forms of UV therapy. Medium-to-high dose UVA-1 also appears to be superior to low dose UVA-1 for sclerosing conditions.
Sclerosing skin diseases treated with UVA-1 include systemic sclerosis (SSc), morphea and sclerodermatous graft vs. host disease (GVHD). These are immune-mediated conditions that lead to skin fibrosis and may be associated with significant morbidity. These conditions share some common features including fibrotic skin changes that may have an active inflammatory stage followed by induration and scarring. Due to the depth of skin involvement, clinical assessment of the degree of active inflammation and depth of involvement is often challenging.
SSc, also called scleroderma, is a rare chronic autoimmune disease that can have a wide range of cutaneous, joint, and internal organ involvement. In the skin, SSc is characterized by enhanced fibroblast activity leading to hypertrophic dermal collagen that results in thickened, less flexible skin. SSc is often divided into two types based on extent of skin involvement: diffuse SSc and limited SSc. Morphea has similar cutaneous changes to SSc but lacks the internal organ involvement. Some of the common subtypes of morphea include circumscribed, linear, and generalized. Sclerodermatous GVHD, a complication of allogenic bone marrow or peripheral blood stem cell transplants, results in fibrotic skin changes that can be widespread and cause morbidity.
Multiple studies report skin improvement in these conditions using UVA-1. This improvement likely involves both dampening inflammation and reducing fibrosis. However, these studies generally lack validated clinical outcome measures. Development of these outcome measures has been slowed by the lack of tools to adequately assess change. Physician assessment, clinical scores, medical imaging, and tools such as a durometer have all been used to attempt to objectively measure changes with therapy over time, but all have limitations.
Patient reported outcomes (PROs) have attracted significant attention in clinical research in the past decade and are required by the FDA for clinical trials. These instruments refer to health outcomes reported directly by the patient who experienced the intervention. Established and validated PRO measures exist and have been used to evaluate multiple medical treatments. While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, PROs have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, PROs may offer a better way to study the impact of treatments like UVA-1.
Purpose and Objectives:
- Primary objective: To assess the degree of improvement seen in the Health Assessment Questionnaire Disability Index (HAQ-DI) after 30 sessions of UVA-1 therapy in treating SSc, morphea, and sclerodermatous GVHD.
- Secondary objectives: After 30 sessions of UVA-1 therapy:
- Assess changes in the Hand Mobility in Scleroderma (HAMIS) score in patients with hand involvement.
- Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients.
- Assess changes in the Modified Rodnan Skin Score (mRSS) in SSc patients.
- Assess changes in the National Institutes of Health (NIH) Likert scale score in GVHD patients.
- Assess changes in durometer scores in all patients.
- Assess changes in PROs
- Compare changes in HAQ-DI scores to changes in LoSCAT, mRSS, NIH Likert scale, durometer, and HAMIS scores, as indicated
Study Design:
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 PROs and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions. In order to more accurately assess the outcome of UVA-1 therapy for each of the three different diseases, patients will be evaluated at the beginning and the end of the study using clinical scoring methods specific to each of the three diseases. Morphea patients will be assessed using LoSCAT, a reliable tool that captures disease activity and damage by assessing skin thickness, erythema, and new lesions/lesion extension. SSc disease activity and severity is more accurately assessed by measuring skin thickness. We will use a specific tool for SSc patients called the modified Rodnan's Skin Score (mRSS), which measures skin thickness on 17 different body areas. Disease activity for GVHD patients differs from morphea and SSc in that this GVHD affects multiple internal organ systems in addition to the skin; thus, a standardized measure is lacking for assessing skin-specific GVHD. Measures such as the MRSS and LoSCAT are also not recommended in clinical trials given these tests' inability to adequately assess the range of sclerotic changes seen in GVHD. Responses to the 2014 NIH criteria for assessing organ involvement in GVHD suggest assessing GVHD sclerotic skin disease activity with a clinician-reported 11-point scale of disease severity. We will therefore use this method and limit the assessment of GVHD patients to a single clinician to eliminate interrater variability. Additional clinical assessments for all patients will include durometry to assess skin hardness and the HAMIS test to assess hand function.
This is a prospective, single arm, clinical trial of UVA-1 therapy for multiple sclerosing skin conditions over 30 treatment sessions. The study will be performed at the University of Utah Dermatology Midvalley Clinic space where the UVA-1 light box is located. Personnel involved in the study will include the PI, the co-investigators, and the study coordinators.
At least 18 participants are needed to account for a 25% drop-out rate, although we plan to recruit 30 in total given the study funding available to meet the costs of all participants' treatments.
- Conditions
- Scleroderma, Systemic, Morphea, Graft Vs Host Disease
- Being tested
- UVA-1 Phototherapy
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Localized, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVA-1 PhototherapyDevice
UVA-1 phototherapy administered as described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Experimental | All enrolled participants will receive UVA-1 phototherapy using a UVA-1 light box two to three times per week for a total of 30 treatment sessions over a 100-day period. The initial UVA-1 dose and subsequent dose increases will be determined according to usual clinical practice and the participant's type of sclerotic disease. Treatment will be held for active redness, burning, pain, or blistering at the treatment site. If symptoms have resolved by the next scheduled treatment, the UVA-1 energy will be reduced by 10 J from the previously delivered dose. Dose escalation may resume after three well-tolerated treatments. Receives: Device: UVA-1 Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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).
Measured: 100 days
Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients after 30 sessions of UVA-1 therapy.
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).
Measured: 100 days
Assess changes in the Modified Rodnan Skin Score (mRSS) in systemic scleroderma patients after 30 sessions of UVA-1 therapy.
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).
Measured: 100 days
Assess changes in the National Institutes of Health (NIH) Likert scale score in GVHD patients after 30 sessions of UVA-1 therapy.
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.
Measured: 100 days
Assess changes in durometer scores in all patients after 30 sessions of UVA-1 therapy.
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.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start7 Jun 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group, open label,
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher B Hansen, University of Utah
- Investigators
- Christopher B. Hansen, M.D., Principal investigator, University of Utah MidValley Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922736
- Sponsor's protocol ID
- IRB_00142027
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2021
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16488295Hassani 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.
PubMed 27519050Poole 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.
PubMed 11188583Filippetti 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.
PubMed 32350931Khanna 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.
PubMed 31342624Kreuter 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.
PubMed 15097958Gambichler 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.
PubMed 30211165Skrzypek-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.
PubMed 30217204Khanna 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.
PubMed 28516167Lee 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.
PubMed 25796139Sandqvist 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.
PubMed 14635312Steen 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.
PubMed 9365087Allanore 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.
PubMed 33115544
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
- ClinicalTrials.gov ID
- NCT04922736
- Acronym / sponsor ID
- IRB_00142027
- Conditions
- Scleroderma, Systemic, Morphea, Graft Vs Host Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ultraviolet (UV) therapy has been used in dermatology for decades. UVA-1 phototherapy uses the longest wavelengths in the UV spectrum from 340-400 nm. It can penetrate the skin deeper than other types of phototherapy and target different cell types including fibroblasts. In sclerosing skin conditions UVA-1 appears to be superior to other forms of UV therapy. Medium-to-high dose UVA-1 also appears to be superior to low dose UVA-1 for sclerosing conditions.
Sclerosing skin diseases treated with UVA-1 include systemic sclerosis (SSc), morphea and sclerodermatous graft vs. host disease (GVHD). These are immune-mediated conditions that lead to skin fibrosis and may be associated with significant morbidity. These conditions share some common features including fibrotic skin changes that may have an active inflammatory stage followed by induration and scarring. Due to the depth of skin involvement, clinical assessment of the degree of active inflammation and depth of involvement is often challenging.
SSc, also called scleroderma, is a rare chronic autoimmune disease that can have a wide range of cutaneous, joint, and internal organ involvement. In the skin, SSc is characterized by enhanced fibroblast activity leading to hypertrophic dermal collagen that results in thickened, less flexible skin. SSc is often divided into two types based on extent of skin involvement: diffuse SSc and limited SSc. Morphea has similar cutaneous changes to SSc but lacks the internal organ involvement. Some of the common subtypes of morphea include circumscribed, linear, and generalized. Sclerodermatous GVHD, a complication of allogenic bone marrow or peripheral blood stem cell transplants, results in fibrotic skin changes that can be widespread and cause morbidity.
Multiple studies report skin improvement in these conditions using UVA-1. This improvement likely involves both dampening inflammation and reducing fibrosis. However, these studies generally lack validated clinical outcome measures. Development of these outcome measures has been slowed by the lack of tools to adequately assess change. Physician assessment, clinical scores, medical imaging, and tools such as a durometer have all been used to attempt to objectively measure changes with therapy over time, but all have limitations.
Patient reported outcomes (PROs) have attracted significant attention in clinical research in the past decade and are required by the FDA for clinical trials. These instruments refer to health outcomes reported directly by the patient who experienced the intervention. Established and validated PRO measures exist and have been used to evaluate multiple medical treatments. While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, PROs have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, PROs may offer a better way to study the impact of treatments like UVA-1.
Purpose and Objectives:
- Primary objective: To assess the degree of improvement seen in the Health Assessment Questionnaire Disability Index (HAQ-DI) after 30 sessions of UVA-1 therapy in treating SSc, morphea, and sclerodermatous GVHD.
- Secondary objectives: After 30 sessions of UVA-1 therapy:
- Assess changes in the Hand Mobility in Scleroderma (HAMIS) score in patients with hand involvement.
- Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients.
- Assess changes in the Modified Rodnan Skin Score (mRSS) in SSc patients.
- Assess changes in the National Institutes of Health (NIH) Likert scale score in GVHD patients.
- Assess changes in durometer scores in all patients.
- Assess changes in PROs
- Compare changes in HAQ-DI scores to changes in LoSCAT, mRSS, NIH Likert scale, durometer, and HAMIS scores, as indicated
Study Design:
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 PROs and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions. In order to more accurately assess the outcome of UVA-1 therapy for each of the three different diseases, patients will be evaluated at the beginning and the end of the study using clinical scoring methods specific to each of the three diseases. Morphea patients will be assessed using LoSCAT, a reliable tool that captures disease activity and damage by assessing skin thickness, erythema, and new lesions/lesion extension. SSc disease activity and severity is more accurately assessed by measuring skin thickness. We will use a specific tool for SSc patients called the modified Rodnan's Skin Score (mRSS), which measures skin thickness on 17 different body areas. Disease activity for GVHD patients differs from morphea and SSc in that this GVHD affects multiple internal organ systems in addition to the skin; thus, a standardized measure is lacking for assessing skin-specific GVHD. Measures such as the MRSS and LoSCAT are also not recommended in clinical trials given these tests' inability to adequately assess the range of sclerotic changes seen in GVHD. Responses to the 2014 NIH criteria for assessing organ involvement in GVHD suggest assessing GVHD sclerotic skin disease activity with a clinician-reported 11-point scale of disease severity. We will therefore use this method and limit the assessment of GVHD patients to a single clinician to eliminate interrater variability. Additional clinical assessments for all patients will include durometry to assess skin hardness and the HAMIS test to assess hand function.
This is a prospective, single arm, clinical trial of UVA-1 therapy for multiple sclerosing skin conditions over 30 treatment sessions. The study will be performed at the University of Utah Dermatology Midvalley Clinic space where the UVA-1 light box is located. Personnel involved in the study will include the PI, the co-investigators, and the study coordinators.
At least 18 participants are needed to account for a 25% drop-out rate, although we plan to recruit 30 in total given the study funding available to meet the costs of all participants' treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group, open label,
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | Experimental | Device: UVA-1 PhototherapyAll enrolled participants will receive UVA-1 phototherapy using a UVA-1 light box two to three times per week for a total of 30 treatment sessions over a 100-day period. The initial UVA-1 dose and subsequent dose increases will be determined according to usual clinical practice and the participant's type of sclerotic disease. Treatment will be held for active redness, burning, pain, or blistering at the treatment site. If symptoms have resolved by the next scheduled treatment, the UVA-1 energy will be reduced by 10 J from the previously delivered dose. Dose escalation may resume after three well-tolerated treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVA-1 PhototherapyUVA-1 phototherapy administered as described in the protocol. | Device | All Study Participants |
Primary outcome
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).
5 secondary outcomes
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
Assess changes in the Localized Scleroderma Assessment Tool (LoSCAT) score in morphea patients after 30 sessions of UVA-1 therapy.
Time frame: 100 days
Assess changes in the Modified Rodnan Skin Score (mRSS) in systemic scleroderma patients after 30 sessions of UVA-1 therapy.
Time frame: 100 days
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
Assess changes in durometer scores in all patients after 30 sessions of UVA-1 therapy.
Time frame: 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 16488295Kreuter 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.
- Background: PubMed 27519050Hassani 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher B. Hansen, M.D. principal investigator
University of Utah MidValley Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVA-1 Phototherapy in people with Scleroderma, Systemic and Morphea, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922736, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.