Actively Recruiting
An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
Led by Psoriasis Treatment Center of Central New Jersey · Updated on 2019-01-30
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Narrowband Ultraviolet-B (UVB) phototherapy as a treatment for adults with moderate to severe chronic plaque-type psoriasis. This pilot study involves 30 patients and aims to assess the response to this phototherapy given three times a week over 12 weeks, followed by evaluations to see how well the treatment effects last through week 36. The study is conducted at a single center and sponsored by the Psoriasis Treatment Center of Central New Jersey. Participants will receive increasing doses of Narrowband UVB phototherapy three times weekly for 12 weeks. This open-label treatment phase is followed by periodic assessments every six weeks up to week 36 to monitor the maintenance of treatment response. The phototherapy is delivered using a device designed to emit ultraviolet B light, targeting the skin affected by psoriasis. During the study, patients will attend regular phototherapy sessions and follow-up visits. Researchers will evaluate changes in psoriasis severity using the Psoriasis Area Severity Index (PASI) score at 12 weeks as the primary outcome. Additional assessments include the Physicians Global Assessment, Body Surface Area affected, and a combined measure of these two at 12 weeks. Patients must be in good general health apart from psoriasis and able to comply with the treatment schedule and visits throughout the trial.
CONDITIONS
Brief Title
An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of chronic plaque-type psoriasis for at least 6 months
- Moderate to severe plaque psoriasis defined by body surface area of 10% or more, PASI score of 12 or higher, and Investigator's Global Assessment of 3 or higher
- Able to provide written informed consent before any study procedures
- Able to attend Narrowband UVB phototherapy sessions three times a week and all required study visits
- In general good health apart from psoriasis as judged by the investigator based on medical history and physical exam
You will not qualify if you...
- Having psoriasis types other than chronic plaque-type, such as pustular, erythrodermic, guttate, or drug-induced psoriasis
- History of photosensitivity
- Use of ustekinumab or anti-IL-17 biologic therapy within 24 weeks before first study dose, or other biologic immune modulators within 12 weeks prior
- Use of any investigational drug within 4 weeks before randomization or within 5 half-lives if known
- Use of oral systemic psoriasis medications within 4 weeks prior (including corticosteroids, methotrexate, acitretin, apremilast, cyclosporine)
- Use of topical psoriasis treatments within 2 weeks before baseline (including corticosteroids, vitamin D analogs, retinoids)
- Recent or planned changes to medications that could affect psoriasis during the trial
- Active infections requiring antibiotics within 2 weeks before baseline
- Received UVB phototherapy within 4 weeks before baseline
- Received PUVA phototherapy within 4 weeks before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Narrowband Ultraviolet-B phototherapy three times weekly.
Three visits per week for 12 weeks
Duration - Up to 24 weeks after treatment
Participants are evaluated every 6 weeks through week 36 to determine maintenance of response.
Visits every 6 weeks until week 36
Trial Site Locations
Total: 1 location
1
Elise Nelson
East Windsor, New Jersey, United States, 08520
Actively Recruiting
Research Team
J
Jerry Bagel, MD
E
Elise Nelson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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