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Phototherapy
NB-UVB vs PUVA for Hand Eczema/Psoriasis
Phase 2
Waitlist Available
Led By Harvey Lui, MD, FRCPC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects should be 18 years old or older
Be older than 18 years old
Must not have
Any serious medical illness that will restrict the patient's ability to receive light treatments, including skin conditions such as skin cancer or severe blistering conditions, or any serious medical conditions affecting the sensation of the extremities (e.g., diabetic neuropathy, cervical stenosis)
Patients known to have a photosensitivity disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every four weeks up to 16 weeks, and at 24 weeks
Awards & highlights
Summary
This trial is testing whether a new treatment, narrow band ultraviolet B (NB-UVB) is better than the current standard treatment, psoralen with long wavelength ultraviolet A radiation (PUVA), for hand psoriasis/eczema.
Who is the study for?
This trial is for adults with severe, chronic hand psoriasis or eczema that's symmetrical. It's open to those who've tried topical steroids without full success. Pregnant or breastfeeding individuals, those with photosensitivity disorders, skin cancer, blistering conditions, or impaired sensation in extremities like from diabetic neuropathy are excluded.Check my eligibility
What is being tested?
The study compares two treatments for stubborn hand skin diseases: topical Psoralen Ultraviolet Light A (t-PUVA) and Narrow Band Ultraviolet Light B (NB-UVB). The goal is to see which one is more effective and safer for patients struggling with these long-lasting skin issues.See study design
What are the potential side effects?
Topical PUVA can cause short-term side effects like redness and itching as well as long-term risks such as increased aging of the skin and higher chances of skin cancer. NB-UVB tends to have fewer side effects but may still lead to similar reactions including mild burning or increased pigmentation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have any serious illnesses that would prevent me from receiving light treatments.
Select...
I have a condition that makes my skin unusually sensitive to sunlight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every four weeks up to 16 weeks, and at 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every four weeks up to 16 weeks, and at 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint will be based on the change in visual cutaneous symptoms as measured by the modified ASI score
Secondary outcome measures
Adverse effects will be assessed every four weeks, including erythema, pruritus, and tanning. This will be assessed using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Hand
Trial Design
2Treatment groups
Active Control
Group I: Topical PUVAActive Control1 Intervention
This single-blinded randomized bilateral left to right controlled comparison clinical trial of 24 weeks duration will compare the efficacy of NB-UVB to t-PUVA. For each patient one hand will be randomly assigned to receive t-PUVA and the other hand will receive NB-UVB. Each hand will receive treatment with either NB-UVB or topical PUVA three times weekly. Treatment will be performed until complete or almost complete clearing of psoriasis/eczema or until 50 exposures (over 16 weeks) have been reached, whichever comes first.
Group II: NB-UVBActive Control1 Intervention
This single-blinded randomized bilateral left to right controlled comparison clinical trial of 24 weeks duration will compare the efficacy of NB-UVB to t-PUVA. For each patient one hand will be randomly assigned to receive t-PUVA and the other hand will receive NB-UVB. Each hand will receive treatment with either NB-UVB or topical PUVA three times weekly. Treatment will be performed until complete or almost complete clearing of psoriasis/eczema or until 50 exposures (over 16 weeks) have been reached, whichever comes first.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,431 Previous Clinical Trials
2,478,873 Total Patients Enrolled
4 Trials studying Vitiligo
95 Patients Enrolled for Vitiligo
Harvey Lui, MD, FRCPCPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
50 Total Patients Enrolled
3 Trials studying Vitiligo
50 Patients Enrolled for Vitiligo
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe hand psoriasis or eczema on both hands, even after using creams.I am 18 years old or older.I am 18 years old or older.I don't have any serious illnesses that would prevent me from receiving light treatments.I haven't treated my hand psoriasis/eczema with creams for 2 weeks or with pills/light therapy for 4 weeks.I have a condition that makes my skin unusually sensitive to sunlight.I have severe hand psoriasis or eczema on both hands.
Research Study Groups:
This trial has the following groups:- Group 1: Topical PUVA
- Group 2: NB-UVB
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.
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