NCT03392337 · Psoriasis Treatment Center of Central New Jersey
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
What this study is about
A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.
View original scientific description
A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.
Interventions
DEVICE
Narrowband UVB phototherapy
Ultraviolet B phototherapy
Primary outcome measures
Psoriasis area severity index score
Time frame: 12 weeks
PASI 75
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type psoriasis for at least 6 months
- Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
- Able to give written informed consent prior to performance of any study related procedures
- Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
- Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
Exclusion criteria
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
- History of photosensitivity
- Subject has used ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
- Patient used topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
- Initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors ) during the trial
- Active infections requiring antibiotics in the 2 weeks prior to Baseline
- Patient received UVB phototherapy within 4 weeks of Baseline.
- Patient received PUVA phototherapy within 4 weeks of Baseline.
Where
- East Windsor, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2019 · Source of record for eligibility and locations