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

Last updated: January 29, 2019
Sponsor: Psoriasis Treatment Center of Central New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rosacea

Scalp Disorders

Rash

Treatment

N/A

Clinical Study ID

NCT03392337
PTC02
  • Ages > 18
  • All Genders

Study 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

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 relatedprocedures

  5. Subject is able to attend Narrowband UVB phototherapy sessions three times a week andall other protocol specified visits

  6. Subject must be in general good health (except for psoriasis) as judged by theInvestigator, based on medical history, physical examination.

Exclusion

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 orother experimental or commercially available biologic immune modulator(s) within 12weeks prior to the first IP dose.

  4. Use of any investigational drug within 4 weeks prior to randomization, or within 5pharmacokinetic/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, orretinoids).

  7. Initiated within 3 months, planned initiation of, or changes to, concomitantmedications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarialdrugs, 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

Total Participants: 30
Study Start date:
November 07, 2017
Estimated Completion Date:
January 01, 2020

Study 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.

Connect with a study center

  • Elise Nelson

    East Windsor, New Jersey 08520
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.