Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922736
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-05
First Post:
2021-06-08
Brief Title:
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1 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
2 Secondary objectives After 30 sessions of UVA-1 therapy
1 Assess changes in the Hand Mobility in Scleroderma HAMIS score in patients with hand involvement
2 Assess changes in the Localized Scleroderma Assessment Tool LoSCAT score in morphea patients
3 Assess changes in the Modified Rodnan Skin Score mRSS in SSc patients
4 Assess changes in the National Institutes of Health NIH Likert scale score in GVHD patients
5 Assess changes in durometer scores in all patients
6 Assess changes in PROs
7 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 lesionslesion 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 Rodnans 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
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
1 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
2 Secondary objectives After 30 sessions of UVA-1 therapy
1 Assess changes in the Hand Mobility in Scleroderma HAMIS score in patients with hand involvement
2 Assess changes in the Localized Scleroderma Assessment Tool LoSCAT score in morphea patients
3 Assess changes in the Modified Rodnan Skin Score mRSS in SSc patients
4 Assess changes in the National Institutes of Health NIH Likert scale score in GVHD patients
5 Assess changes in durometer scores in all patients
6 Assess changes in PROs
7 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 lesionslesion 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 Rodnans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None