Recruiting

Narrowband UVB

Sponsor:

Psoriasis Treatment Center of Central New Jersey

Code:

NCT03392337

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Narrowband UVB phototherapy

Study Details

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.

Conditions

Psoriasis

Study ID

NCT03392337

Start date

Nov 7, 2017

Status verified date

Jan, 2019

Completion date

Jan 1, 2020

Anticipated

Primary completion date

Dec 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Label Narrowband UVB phototherapy

Open Label Narrowband UVB phototherapy for 12 weeks.

Interventions

Narrowband UVB phototherapy

Ultraviolet B phototherapy

Primary outcome measure

  • Psoriasis area severity index score [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Elise Nelson

Recruiting

East Windsor, New Jersey, United States, 08520

Contacts

Principal Investigator:

Jerry Bagel, MD

More Information

Sponsor

Psoriasis Treatment Center of Central New Jersey

Last update posted

Jan 30, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Psoriasis Treatment Center of Central New Jersey on 2019-01-30.