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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 100 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 100 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed.
Secondary outcome measures
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 moreTrial 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
1,098 Previous Clinical Trials
1,778,600 Total Patients Enrolled
1 Trials studying Scleroderma
5 Patients Enrolled for Scleroderma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I can attend two UVA1 therapy sessions every week.I have not used tanning beds or had excessive sun exposure in the last month.I am 18 years old or older.I cannot attend all required study visits.I am taking medication that increases my skin's sensitivity to light.I haven't used strong skin creams other than moisturizers in the last 2 weeks.You have had bad reactions to sunlight in the past.My scleroderma affects both of my hands equally.I have not had UV light therapy in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: UVA-1 Treated hand
- Group 2: The untreated hand
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers have been accepted into this clinical trial?
"Affirmative. Clinicaltrials.gov hosts the report which attests to this medical trial's active recruitment phase, beginning on December 12th 2020 and last edited on May 20th 2022. The study is searching for 30 individuals at a single site."
Answered by AI
Are enrollments for this experiment still being accepted?
"Affirmative. Evidence found on clinicaltrials.gov affirms that this medical investigation, which was originally published on December 12th 2020, is currently recruiting participants. Approximately 30 people need to be enrolled from one distinct site."
Answered by AI
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