Psoriasis Clinical Trial

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

Summary

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.

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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Psoriasis

Estimated Enrollment:

30

Study ID:

NCT03392337

Recruitment Status:

Unknown status

Sponsor:

Psoriasis Treatment Center of Central New Jersey

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There is 1 Location for this study

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Elise Nelson
East Windsor New Jersey, 08520, United States More Info
Jerry Bagel
Contact
609-443-4500
[email protected]
Elise Nelson
Contact
6094434500
Jerry Bagel, MD
Principal Investigator
Brian R Keegan, MD, PhD
Sub-Investigator
David S Nieves, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

30

Study ID:

NCT03392337

Recruitment Status:

Unknown status

Sponsor:


Psoriasis Treatment Center of Central New Jersey

How clear is this clinincal trial information?

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