NCT03392337 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
| NCT ID | NCT03392337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Psoriasis Treatment Center of Central New Jersey |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-11-07 |
| Primary Completion | 2019-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2017-11-07 with a primary completion date of 2019-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03392337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03392337 currently recruiting?
Yes, NCT03392337 is actively recruiting participants. Contact the research team at dreamacres1@aol.com for enrollment information.
Where is the NCT03392337 trial being conducted?
This trial is being conducted at East Windsor, United States.
Who is sponsoring the NCT03392337 clinical trial?
NCT03392337 is sponsored by Psoriasis Treatment Center of Central New Jersey. The trial plans to enroll 30 participants.
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