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Phototherapy

UVA-1 Phototherapy for Scleroderma

N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to engage in twice weekly UVA1 sessions
Age of at least 18-years-old
Must not have
Commercial tanning or excessive sun exposure in the 4 weeks prior to entering the study
Inability to complete study visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 100 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a single-blind, prospective, randomized (dominant/non-dominant hand) comparator design to assess the effect of high dose (80-120 J/cm2) UVA1 therapy on hand function in scleroderma in a paired t-test design. This study will be placebo-controlled (with a UV-blocking gloved hand), cross-over, randomized clinical trial.

Who is the study for?
This trial is for adults with scleroderma affecting both hands equally, who can attend twice-weekly UVA1 sessions and won't change their systemic therapy during the first 100 days. It's not for those with recent tanning or sun exposure, on photosensitizing meds, unable to complete visits, pregnant or planning pregnancy, using certain topical therapies recently, intolerant to UV light, or disqualified by the investigator.
What is being tested?
The study tests if UVA-1 Phototherapy improves hand function in scleroderma patients. Participants' dominant or non-dominant hand will receive 30 sessions of high dose UVA-1 treatment. The study measures hand mobility and skin changes before allowing treatment on the other hand. It's a single-blind trial comparing treated vs UV-blocked gloved hands.
What are the potential side effects?
Potential side effects from UVA-1 Phototherapy may include skin irritation or burns, increased risk of skin aging or cancer due to UV exposure. Specific side effects related to scleroderma patients undergoing this therapy are not well documented but could be identified during this detailed study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can attend two UVA1 therapy sessions every week.
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I am 18 years old or older.
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My scleroderma affects both of my hands equally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not used tanning beds or had excessive sun exposure in the last month.
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I cannot attend all required study visits.
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I am taking medication that increases my skin's sensitivity to light.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 100 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 100 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed.
Secondary study objectives
Change in CHFDS score from baseline to after 30 UVA-1 treatments of treated hand.
Change in HAMIS score from baseline to after 30 UVA-1 treatments of treated hand.
Hand
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: UVA-1 Treated handExperimental Treatment1 Intervention
This hand will be treated with UVA-1 phototherapy.
Group II: The untreated handActive Control1 Intervention
This hand will be gloved when the patient undergoes UVA-1 phototherapy treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UVA-1 Phototherapy
2012
N/A
~20

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,140 Previous Clinical Trials
1,697,698 Total Patients Enrolled
1 Trials studying Scleroderma
5 Patients Enrolled for Scleroderma

Media Library

UVA-1 Phototherapy (Phototherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04875078 — N/A
Scleroderma Research Study Groups: UVA-1 Treated hand, The untreated hand
Scleroderma Clinical Trial 2023: UVA-1 Phototherapy Highlights & Side Effects. Trial Name: NCT04875078 — N/A
UVA-1 Phototherapy (Phototherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04875078 — N/A
~0 spots leftby Dec 2024
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