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NCT04922736 · ClinicalTrials.gov registry record · NA
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
A NA study of Graft Vs Host Disease and Scleroderma, Systemic, sponsored by University of Utah.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04922736: Active NA study of Graft Vs Host Disease and Scleroderma, Systemic, sponsored by University of Utah.
NCT04922736 is a NA study of Graft Vs Host Disease and Scleroderma, Systemic that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 30 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04922736, a NA study of Graft Vs Host Disease and Scleroderma, Systemic, is active but no longer recruiting, sponsored by University of Utah.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE UVA-1 Phototherapy
Study Locations (1)
Utah
- University of Utah Dermatology - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2026-06 |
| Phase | NA |
What the registry record for NCT04922736 still lists
NCT04922736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Graft Vs Host Disease appearing as the primary indexed condition, and to 1 intervention - of which UVA-1 Phototherapy is the first listed.
NCT04922736 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04922736 about?
NCT04922736 is a clinical study titled "Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases". 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 dis...
What is the current status of trial NCT04922736?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2021-06-07. Estimated completion is 2026-06.
What conditions does trial NCT04922736 study?
This clinical trial studies the following conditions: Graft Vs Host Disease, Scleroderma, Systemic, Morphea.
What interventions are being tested in trial NCT04922736?
The interventions under investigation include: UVA-1 Phototherapy (DEVICE).
Who is sponsoring clinical trial NCT04922736?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04922736 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04922736's enrollment target sits among peer trials
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