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

NCT02107482 | Completed Results

• 1 other identifier: Levia
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (2)

• The Percentage of Change in Target Lesion Score

  12 weeks

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

  12 weeks

Study Arms (2)

Levia Narrow Band UVB

ACTIVE COMPARATOR

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.

Device: Levia Narrow Band UVB

Levia sham/visible-light source

SHAM COMPARATOR

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.

Device: Levia sham/visible-light source

Interventions

Levia Narrow Band UVB DEVICE

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

Levia Narrow Band UVB

Levia sham/visible-light source DEVICE

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.

Levia sham/visible-light source

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Dermatology Research, Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 25116969 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nicole Dumont
• Organization: Tufts Medical Center

ndonovan1@tuftsmedicalcenter.org

617 636 7462

Study Officials

• Alice b Gottlieb, MD, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 31, 2017
• Results First Posted: February 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)