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Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis

Primary Purpose

Psoriasis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Levia Narrow Band UVB

Levia sham/visible-light source

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:

Adults 18 years or older with bilateral psoriasis plaques, in general good health as determined by the Principal Investigator by medical history and physical exam.
Able to understand consent procedure
Able to comply with protocol activities
Must have baseline symmetric target lesions with baseline Target Lesion Score (TLS) of 6 or higher (scale of 0-12), i.e., moderate in intensity for each target.

Target Lesion Scoring: Thickness, scaling and erythema of the plaques are rated each on a scale of 0-4. The three scores are summed. The minimum score is 0; the maximum is 12. Scores of 6 or greater are considered moderate to severe.

Exclusion Criteria:

Patients less than 18 years old
Patients not able to understand consent procedure
Patients unable to comply with protocol activities
Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English
Baseline target lesions scores of less than 6
Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity
Patients receiving concomitant phototherapy to test sites
Patient receiving topical medication to test sites within 2 weeks of study initiation
Patient receiving Methotrexate, Acitretin, Cyclosporine, or other oral medications for psoriasis within 4 weeks of study initiation
Patients receiving Etanercept (Enbrel®) within the past 2 months of study initiation
Patients receiving Infliximab (Remicade®), Ustekinumab (Stelara®), Golimumab (Simponi®) Adalimumab (Humira®) or Alefacept (Amevive®) within the past 3 months prior to study initiation
Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study ignition
Systemic corticosteroid therapy within the past month
Concurrent use of prohibited medications

Sites / Locations

Dermatology Research, Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Levia Narrow Band UVB

Levia sham/visible-light source

Arm Description

Levia Narrow Band UVB dosing for subjects with skin type I: starting dose of 195 mj/cm2, for subjects with skin type II: starting dose of 330 mj/cm2, for subjects with skin type III: starting dose of 390 mj/cm2, for subjects with skin type IV: starting dose of 495 mj/cm2, for subjects with skin type V: starting dose of 525 mj/cm2, for subjects with skin type VI: starting dose of 600 mj/cm2. The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness.

the light is produced using the same Levia® device. Levia® enable the user to switch off the UVB light and only produce visible light spectrum.

Outcomes

Primary Outcome Measures

The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12

Secondary Outcome Measures

The Percentage of Change in Target Lesion Score

Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12

Full Information

NCT ID

NCT02107482

First Posted

April 4, 2014

Last Updated

March 2, 2017

Sponsor

Tufts Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02107482

Brief Title

Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis

Official Title

Bilateral Comparator, Sham-Light Source Controlled, Assessor Blinded Clinical Trial of Localized Narrow Band-Ultraviolet B (NB-UVB) (Levia®) Treatment for Plaque-type Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to test the effect of a localized narrow band ultraviolet (NB-UVB) phototherapy compared to visible light that does not produce UVB on the clearance of psoriasis plaques and resolution of itching. Localized NB-UVB (Levia®) phototherapy device is cleared by the U.S Food and Drug Administration (FDA).

Detailed Description

This will be an ascending dose study with treatments three times per week, initial treatment dose and increasing regimen is adjusted according to the subject skin type. A suggested treatment regimen schedule provided from Lerner Medical Devices, Inc: For subjects with skin type I: starting dose of 195 mj/cm2, for subjects with skin type II: starting dose of 330 mj/cm2, for subjects with skin type III: starting dose of 390 mj/cm2, for subjects with skin type IV: starting dose of 495 mj/cm2, for subjects with skin type V: starting dose of 525 mj/cm2, for subjects with skin type VI: starting dose of 600 mj/cm2. The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness.

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

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levia Narrow Band UVB

Arm Type

Active Comparator

Arm Description

Arm Title

Levia sham/visible-light source

Arm Type

Sham Comparator

Arm Description

the light is produced using the same Levia® device. Levia® enable the user to switch off the UVB light and only produce visible light spectrum.

Intervention Type

Device

Intervention Name(s)

Levia Narrow Band UVB

Intervention Description

The device's spectral output is is Narrow Band UVB (NB-UVB) (NB-Levia): 308-312 nm

Intervention Type

Device

Intervention Name(s)

Levia sham/visible-light source

Intervention Description

the light spectrum is in the range of 400-700nm, the light is produced using the same Levia® device. Levia® enable the user to switch off the UVB light and only produce visible light spectrum.

Primary Outcome Measure Information:

Title

The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

The Percentage of Change in Target Lesion Score

Time Frame

12 weeks

Title

Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults 18 years or older with bilateral psoriasis plaques, in general good health as determined by the Principal Investigator by medical history and physical exam. Able to understand consent procedure Able to comply with protocol activities Must have baseline symmetric target lesions with baseline Target Lesion Score (TLS) of 6 or higher (scale of 0-12), i.e., moderate in intensity for each target. Target Lesion Scoring: Thickness, scaling and erythema of the plaques are rated each on a scale of 0-4. The three scores are summed. The minimum score is 0; the maximum is 12. Scores of 6 or greater are considered moderate to severe. Exclusion Criteria: Patients less than 18 years old Patients not able to understand consent procedure Patients unable to comply with protocol activities Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English Baseline target lesions scores of less than 6 Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity Patients receiving concomitant phototherapy to test sites Patient receiving topical medication to test sites within 2 weeks of study initiation Patient receiving Methotrexate, Acitretin, Cyclosporine, or other oral medications for psoriasis within 4 weeks of study initiation Patients receiving Etanercept (Enbrel®) within the past 2 months of study initiation Patients receiving Infliximab (Remicade®), Ustekinumab (Stelara®), Golimumab (Simponi®) Adalimumab (Humira®) or Alefacept (Amevive®) within the past 3 months prior to study initiation Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study ignition Systemic corticosteroid therapy within the past month Concurrent use of prohibited medications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice b Gottlieb, MD, PhD

Organizational Affiliation

Tufts Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Research, Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25116969

Citation

Levin AA, Aleissa S, Dumont N, Martinez F, Donovan C, Au SC, Hasanain A, Gottlieb AB. A randomized, prospective, sham-controlled study of localized narrow-band UVB phototherapy in the treatment of plaque psoriasis. J Drugs Dermatol. 2014 Aug;13(8):922-6.

Results Reference

derived

Learn more about this trial

Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis

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