Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elise Nelson

East Windsor, New Jersey, 08520, United States

Location status: Recruiting

Location contact

Brian R Keegan, MD, PhD

SUB_INVESTIGATOR

David S Nieves, MD

SUB_INVESTIGATOR

Elise Nelson

CONTACT

6094434500

Jerry Bagel

CONTACT

[email protected]

609-443-4500

Jerry Bagel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Narrowband UVB phototherapy

Device

Ultraviolet B phototherapy

Primary outcomes

  1. Psoriasis area severity index score

    Time frame: 12 weeks

    PASI 75

Secondary outcomes

  1. Physicians Global Assessment

    Time frame: 12 weeks

    PGA improvement

  2. Body Surface Area

    Time frame: 12 weeks

    BSA improvement

  3. Physician's Global Assessments multiplied by Body surface area

    Time frame: 12 weeks

    PGA x BSA

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Nelson

CONTACT

[email protected]

6094434500

Jerry Bagel, MD

CONTACT

[email protected]

6094434500

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2018
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.