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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

Primary Purpose

Psoriasis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Narrowband UVB phototherapy

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Elise NelsonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Narrowband UVB phototherapy

Arm Description

Open Label Narrowband UVB phototherapy for 12 weeks.

Outcomes

Primary Outcome Measures

Psoriasis area severity index score

PASI 75

Secondary Outcome Measures

Physicians Global Assessment

PGA improvement

Body Surface Area

BSA improvement

Physician's Global Assessments multiplied by Body surface area

PGA x BSA

Full Information

NCT ID

NCT03392337

First Posted

December 29, 2017

Last Updated

January 29, 2019

Sponsor

Psoriasis Treatment Center of Central New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT03392337

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 7, 2017 (Actual)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Psoriasis Treatment Center of Central New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open Label Narrowband UVB phototherapy

Arm Type

Experimental

Arm Description

Open Label Narrowband UVB phototherapy for 12 weeks.

Intervention Type

Device

Intervention Name(s)

Narrowband UVB phototherapy

Intervention Description

Ultraviolet B phototherapy

Primary Outcome Measure Information:

Title

Psoriasis area severity index score

Description

PASI 75

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Physicians Global Assessment

Description

PGA improvement

Time Frame

12 weeks

Title

Body Surface Area

Description

BSA improvement

Time Frame

12 weeks

Title

Physician's Global Assessments multiplied by Body surface area

Description

PGA x BSA

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jerry Bagel, MD

Phone

6094434500

dreamacres1@aol.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elise Nelson

Phone

6094434500

enelson@windsordermatology.com

Facility Information:

Facility Name

Elise Nelson

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Individual Site Status

Recruiting

Facility Contact: