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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Device: Narrowband UVB phototherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Recruiting
      • Elise Nelson
      • Contact: Jerry Bagel; Phone Number: 609-443-4500; Email: dreamacres1@aol.com
      • Contact: Elise Nelson; Phone Number: 6094434500
      • Sub-Investigator: Brian R Keegan, MD, PhD
      • Sub-Investigator: David S Nieves, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label Narrowband UVB phototherapy; Open Label Narrowband UVB phototherapy for 12 weeks.	Device: Narrowband UVB phototherapy; Ultraviolet B phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis area severity index score	PASI 75	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physicians Global Assessment	PGA improvement	12 weeks
Body Surface Area	BSA improvement	12 weeks
Physician's Global Assessments multiplied by Body surface area	PGA x BSA	12 weeks

Collaborators and Investigators

• Sponsor: Psoriasis Treatment Center of Central New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PTC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes