N/A
Completed N=21
Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis
Source: ClinicalTrials.gov NCT02107482 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: 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 — 47.6; 33.3 percentage of lesions changed
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
47.6; 33.3 | — |
| SECONDARY The Percentage of Change in Target Lesion Score |
47; 29 | — |
| SECONDARY Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12 |
62; 27 | — |
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
Data sourced from ClinicalTrials.gov (NCT02107482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.