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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

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ClinicalTrials.gov Identifier: NCT03392337
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

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.

Condition or disease Intervention/treatment Phase
Psoriasis Device: Narrowband UVB phototherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Open Label Narrowband UVB phototherapy
Open Label Narrowband UVB phototherapy for 12 weeks.
Device: Narrowband UVB phototherapy
Ultraviolet B phototherapy




Primary Outcome Measures :
  1. Psoriasis area severity index score [ Time Frame: 12 weeks ]
    PASI 75


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392337


Contacts
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Contact: Jerry Bagel, MD 6094434500 dreamacres1@aol.com
Contact: Elise Nelson 6094434500 enelson@windsordermatology.com

Locations
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United States, New Jersey
Elise Nelson Recruiting
East Windsor, New Jersey, United States, 08520
Contact: Jerry Bagel    609-443-4500    dreamacres1@aol.com   
Contact: Elise Nelson    6094434500      
Principal Investigator: Jerry Bagel, MD         
Sub-Investigator: Brian R Keegan, MD, PhD         
Sub-Investigator: David S Nieves, MD         
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey

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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT03392337     History of Changes
Other Study ID Numbers: PTC02
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases