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

NCT03392337 | Recruiting FDA Device

• 1 other identifier: PTC02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Psoriasis area severity index score

  PASI 75

  12 weeks

Secondary Outcomes (3)

• Physicians Global Assessment

  12 weeks

• Body Surface Area

  12 weeks

• Physician's Global Assessments multiplied by Body surface area

  12 weeks

Study Arms (1)

Open Label Narrowband UVB phototherapy

EXPERIMENTAL

Open Label Narrowband UVB phototherapy for 12 weeks.

Device: Narrowband UVB phototherapy

Interventions

Narrowband UVB phototherapy DEVICE

Ultraviolet B phototherapy

Open Label Narrowband UVB phototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead

Study Sites (1)

Elise Nelson

East Windsor, New Jersey, 08520, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jerry Bagel, MD

CONTACT

6094434500; dreamacres1@aol.com

Elise Nelson

CONTACT

6094434500; enelson@windsordermatology.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 5, 2018
• Study Start: November 7, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)