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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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03392337

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Psoriasis Treatment Center of Central New Jersey

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Psoriasis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Elise Nelson, East Windsor, New Jersey

Status

Recruiting

Address

Elise Nelson

East Windsor, New Jersey, 08520

Site Contact

Jerry Bagel

dreamacres1@aol.com

609-443-4500

Nearest Location

Site Contact

Jerry Bagel

dreamacres1@aol.com

609-443-4500

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