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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 | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT03392337•Psoriasis Treatment Center of Central New Jersey

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Elise Nelson

East Windsor, New Jersey, United States

Key Dates

Start Date

November 7, 2017

Primary Completion Date

December 1, 2019

Completion Date

January 1, 2020

Last Updated

January 30, 2019

Enrollment

ESTIMATED participants

Conditions

Psoriasis

Interventions

Narrowband UVB phototherapy

DEVICE

Contacts

Jerry Bagel, MD

CONTACT

6094434500 dreamacres1@aol.com

Elise Nelson

CONTACT

6094434500 enelson@windsordermatology.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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