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

Study Overview
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Brief Summary
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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.

Detailed Description
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30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Device: Narrowband UVB phototherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Narrowband UVB phototherapy<br>Open Label Narrowband UVB phototherapy for 12 weeks. | Device: Narrowband UVB phototherapy<br>* Ultraviolet B phototherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis area severity index score | PASI 75 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians Global Assessment | PGA improvement | 12 weeks | 
| Body Surface Area | BSA improvement | 12 weeks | 
| Physician's Global Assessments multiplied by Body surface area | PGA x BSA | 12 weeks |