Evaluating Narrowband UVB Phototherapy for Moderate-to-Severe Psoriasis

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

This study is testing if Narrowband UVB phototherapy can help people with moderate-to-severe psoriasis feel better after 12 weeks of treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Psoriasis Treatment Center of Central New Jersey (Academic / other)
• Drugs / interventions: ustekinumab, methotrexate
• Locations: 1 site (East Windsor, New Jersey)
• Trial ID: NCT03392337 on ClinicalTrials.gov

What this trial studies

This pilot study involves 30 patients with moderate-to-severe plaque psoriasis receiving Narrowband Ultraviolet-B phototherapy three times a week for 12 weeks. The treatment aims to assess the efficacy of this therapy in improving psoriasis symptoms. Patients will be monitored for response maintenance through week 36, with evaluations occurring every six weeks after the treatment period. The study focuses on determining the effectiveness of this phototherapy approach in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic plaque-type psoriasis that is moderate to severe.

Not a fit: Patients with forms of psoriasis other than chronic plaque-type or those with a history of photosensitivity may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate-to-severe psoriasis.

How similar studies have performed: Previous studies have shown promise with Narrowband UVB phototherapy, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female adults ≥ 18 years of age.
2. Diagnosis of chronic plaque-type psoriasis for at least 6 months
3. Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
4. Able to give written informed consent prior to performance of any study related procedures
5. Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
6. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
2. History of photosensitivity
3. 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.
4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
5. 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).
6. 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).
7. 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
8. Active infections requiring antibiotics in the 2 weeks prior to Baseline
9. Patient received UVB phototherapy within 4 weeks of Baseline.
10. Patient received PUVA phototherapy within 4 weeks of Baseline.

Where this trial is running

East Windsor, New Jersey

• Elise Nelson — East Windsor, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Jerry Bagel, MD

Conditions Psoriasis