Clinical trial NCT02107482: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: The Percentage of Change in Target Lesion Score
timeFrame: 12 weeks
measure: Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dermatology Research, Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Alice b Gottlieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.