An interventional study of UVA-1 Phototherapy in Scleroderma, Systemic, Morphea and Graft Vs Host Disease, sponsored by University of Utah. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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.
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:
Secondary objectives: After 30 sessions of UVA-1 therapy:
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.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 30 is below the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: UVA-1 Phototherapy
UVA-1 phototherapy administered as described in the protocol.
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).
Time frame: 100 days
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).
Time frame: 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).
Time frame: 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).
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.
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.
Time frame: 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.
Time frame: 100 days
Plan to share: No
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